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Shanghai opens fully online FIE registration via cross-border digital identity: the Shanghai–Singapore first

  • Shanghai has launched China’s first fully online, cross-border registration service for foreign-invested enterprises built on cross-border digital identity authentication: under the Shanghai–Singapore digital-trust channel, a Singapore investor completed company registration in the Hongqiao area entirely online in about two days.
    上海推出全国首个基于跨境数字身份认证的外资企业登记全程网办服务：依托沪新数字信任通道，一名新加坡投资者在虹桥区域全程线上完成外资企业登记，约两天即取得营业执照。
  • The pilot removes the classic bottleneck of cross-border company formation — physical notarisation and authentication of identity and signature documents — by letting the authorised signatory of an overseas investor complete identity verification and electronic signing online.
    该试点破解了跨境设立企业长期存在的瓶颈——身份与签字文件的线下公证认证——境外投资者的授权签字人可全程在线完成身份核验与电子签署。
  • The first landed case was registered in Qingpu’s Xihongqiao enterprise-service hub: an entity under Singapore-based IFBH, a food-industry investor, went from submission of documents to receipt of the business licence in two days, through the municipal market-regulation authorities’ online review.
    首个落地案例在西虹桥企业综合服务中心所在的青浦完成登记：新加坡IFBH公司旗下的一家食品企业从递交材料到拿到营业执照全程仅用两天，由市场监管部门在线审查快速发照。
  • Shanghai’s stated direction is to keep widening the cross-border digital-trust network — expanding the service scope and chain, with the goal of eventually enabling two-way online registration for Shanghai enterprises going to Singapore and Singapore investors coming to Shanghai.
    上海的既定方向是持续拓展跨境数字互信合作网络、延伸服务范围与服务链条，并计划最终实现上海企业赴新加坡与新加坡投资者来沪登记的双向网办。
  • The development sits on the broader foundation of China’s accession to the Hague Apostille Convention (effective November 2023), which simplified authentication of foreign public documents; the digital-identity route now removes a further layer of paperwork for investors from partner jurisdictions.
    该进展建立在中国加入海牙《取消外国公文书认证要求的公约》（2023年11月生效）简化外国公文书认证的基础之上；数字身份通道又为来自合作法域的投资者省去一层纸质程序。
  • For overseas investors setting up in Shanghai, the practical takeaways are: for investors from Singapore the fully online route is now proven; for investors from other jurisdictions, confirming whether the digital-trust channel covers your market — and otherwise relying on the Apostille route plus e-signature — determines how much of the formation process can be done remotely.
    对拟在上海设立企业的境外投资者，实务要点是：新加坡投资者现可走已验证的全程网办路径；其他法域投资者则应确认数字信任通道是否覆盖其市场——否则依托附加证明书路径加电子签名——这决定设立流程中有多少环节可远程完成。

Shanghai opens fully online FIE registration via cross-border digital identity: the Shanghai–Singapore first | 上海开通跨境数字身份认证外资全程网办：沪新通道设立企业可”两天拿照”

Overview

Company formation in China has long required a foreign investor to deliver identity and signature documents in a form acceptable to the Chinese registration authority — traditionally notarised and authenticated abroad, then reviewed against the physical file. In 2026 Shanghai removed that bottleneck for investors from at least one jurisdiction, and is building the machinery to extend it further.

According to the Shanghai municipal government, Shanghai launched China’s first fully online foreign-invested enterprise (FIE) registration service built on cross-border digital identity authentication. Using the Shanghai–Singapore cross-border digital-trust channel, an authorised signatory of an overseas investor can complete identity verification and electronic signing entirely online. The first landed case was registered in Qingpu district: a food-industry entity under Singapore-based IFBH received its business licence about two days after submitting its documents, with the market-regulation authority completing online review and licence issuance.

How the digital-trust route works

The service is described by Shanghai’s official reporting as resting on cross-border digital identity authentication — an arrangement through which an investor’s identity and signing authority are verified against recognised credentials in the partner jurisdiction, rather than by paper notarisation and consular or apostille authentication of every document.

In operation, the overseas investor’s authorised signatory logs in remotely, completes identity verification, and electronically signs the formation documents. The market-regulation side reviews online and issues the electronic business licence. In the documented case, the time from submission to licence was about two days — against a conventional process that, for a fully remote foreign investor, typically involves weeks of document preparation and authentication.

The service was first made available in the Hongqiao international open-hub area and registered through the Xihongqiao enterprise-service hub in Qingpu, which hosts the integrated service windows for cross-border matters. Shanghai’s stated roadmap is to keep expanding the cross-border digital-trust cooperation network, widen the service scope and chain, and eventually support two-way online registration — Shanghai enterprises entering Singapore and Singapore investors entering Shanghai.

The wider foundation: the Hague Apostille era

The digital-identity route is not the only recent change in how foreign documents are accepted in China. Since China’s accession to the Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents took effect in November 2023, public documents from other contracting states need only an Apostille certificate rather than consular legalisation. That change already compressed the authentication step for jurisdictions party to the Convention. The Shanghai digital-trust channel goes further for covered jurisdictions by removing the document-authentication step altogether for identity and signature.

What this means for overseas investors

  • For Singapore investors: the fully online route is proven. If your group incorporates through Singapore, the Shanghai digital-trust channel can cut formation from weeks to days, subject to the specifics of each case (scope of business, nominee arrangements, registered address).
  • For investors from other jurisdictions: two routes now apply. Confirm whether Shanghai’s digital-trust coverage has been extended to your market. Where it has not, the practical fast path remains: Apostille-certified documents (for Convention parties) plus remote e-signature where the registration authority accepts it, with the remaining in-person or paper steps handled by the authorised representative in China.
  • Registered address and entity choices still matter. Digital formation does not remove the need for a lawful registered address in Shanghai or the choice of entity form (WFOE, joint venture, branch, representative office); those decisions still shape the registration particulars.
  • Watch the roadmap. Two-way Shanghai–Singapore online registration and expansion to more jurisdictions are stated objectives; companies planning China entry should time their formation strategy against the roll-out.

Practical steps

  • If you are a Singapore-based investor planning a Shanghai entity, contact the Xihongqiao or Hongqiao enterprise-service hub to confirm the current scope and documentation requirements of the cross-border digital-identity route.
  • For non-Singapore investors, verify (a) whether your jurisdiction is party to the Hague Apostille Convention and (b) whether the digital-trust channel covers your market; structure the authentication plan accordingly.
  • Prepare the underlying corporate documents early (board resolutions authorising the signatory, passport copies, proof of address), because even in digital routes the authorisation chain must be clean.
  • Decide the registered address and entity form before starting, and line up the local agent or contact person for any residual paper steps.
  • Reconfirm the current service scope when you start the process, as the pilot is being expanded incrementally.

Sources

  • 上海市人民政府 — 青浦政务服务东中西全覆盖跑出”加速度”（全国首个基于跨境数字身份认证的外资企业登记全程网办在虹桥落地、创星食品案例）: https://www.shanghai.gov.cn/nw15343/20260825/7783833a86f741e48daa8fde70da7c0f.html
  • 东方财富网（2026-08-21）— 上海数字治理三连发（沪新跨境数字身份认证落地与2天拿证场景梳理）: https://caifuhao.eastmoney.com/news/20260821171248365276820
  • 上海市人民政府新闻发布 — 市政府新闻发布会问答实录（2026年9月3日，上海国际贸易中心”十五五”规划与外资便利化部署）: https://www.shanghai.gov.cn/nw9820/20260903/cfcb7a375569474796607ea6015fcd70.html

Related reading

  • see also: the FIE registration timeline and online licence issuance (online-fie-registration-e-business-licence)
  • see also: one-stop FDI service windows and their coverage (one-stop-fdi-service-windows)

上海开通跨境数字身份认证外资全程网办：沪新通道设立企业可”两天拿照”

概述

在中国设立企业，长期以来要求境外投资者以登记机关可接受的形式提交身份与签字文件——传统上需在境外公证认证，再与纸质档案核对。2026年，上海至少为一个法域的投资者拆除了这一瓶颈，并正在建设将其进一步推广的机制。

据上海市政府披露，上海推出全国首个基于跨境数字身份认证的外资企业登记全程网办服务。依托沪新跨境数字信任通道，境外投资者的授权签字人可全程在线完成身份核验与电子签署。首个落地案例登记于青浦区：新加坡IFBH公司旗下的一家食品类企业递交材料后约两天取得营业执照，由市场监管部门在线审查并快速发照。

数字信任通道如何运作

上海市官方报道将其描述为依托跨境数字身份认证：投资者的身份与签署权限，依据合作法域中经认可的凭证加以验证，而非对每份文件做纸质公证与领事或附加证明书认证。

操作上，境外投资者的授权签字人远程登录、完成身份核验并电子签署设立文件；市场监管侧在线审查并签发电子营业执照。在有据可查的案例中，从递交到领照约两天——相比之下，完全远程的境外投资者走传统流程通常需数周准备与认证文件。

该服务率先在虹桥国际开放枢纽区域推出，经青浦西虹桥企业综合服务中心落地——该中心设有跨境事项综合服务窗口。上海的既定路线是：持续拓展跨境数字互信合作网络，扩大服务范围、延伸服务链条，最终实现双向网办——上海企业赴新加坡、新加坡投资者来上海。

更广的基础：海牙附加证明书时代

数字身份路径并非外国文件在华被接受的唯一近期变化。自中国加入海牙《取消外国公文书认证要求的公约》于2023年11月生效以来，来自其他缔约国的公文书仅需附加证明书而无需领事认证。这一变化已压缩了公约缔约法域的认证环节。上海数字信任通道则更进一步：对覆盖法域，身份与签字环节的文书认证被整体取消。

对境外投资者的含义

  • 新加坡投资者：全程网办路径已验证。 若贵集团通过新加坡主体在沪设企，沪新数字信任通道可把设立周期从数周压缩至数日（视经营范围、代持安排、注册地址等个案情况而定）。
  • 其他法域投资者：现有两条路径。 先确认上海数字信任覆盖是否已扩至贵市场。若未覆盖，实务快路径仍是：附加证明书认证文件（公约缔约方适用）加登记机关接受的远程电子签名，其余需现场或纸质的环节由在华授权代表处理。
  • 注册地址与主体选择仍重要。 数字化设立并不免除上海合法注册地址的要求，也不替代主体形式选择（外商独资、合资、分公司、代表处）；这些决策仍决定登记要素。
  • 关注路线图。 沪新双向网办与更多法域扩容是既定目标；拟进入中国的企业应结合推广节奏安排设立策略。

实务建议

  • 若您是拟在上海设企的新加坡投资者，联系西虹桥或虹桥企业服务中心，确认跨境数字身份通道当前的服务范围与文件要求。
  • 非新加坡投资者：核实（a）贵司法辖区是否为海牙附加证明书公约缔约方，（b）数字信任通道是否覆盖贵市场，并据此安排认证方案。
  • 尽早准备底层公司文件（授权签字人的董事会决议、护照复印件、地址证明），因为即使在数字路径下，授权链条也必须清晰。
  • 启动前确定注册地址与主体形式，并为残余纸质环节安排本地代理人或联系人。
  • 因试点为渐进扩容，办理时再次确认最新服务范围。

来源

  • 上海市人民政府 — 青浦政务服务东中西全覆盖跑出”加速度”（全国首个基于跨境数字身份认证的外资企业登记全程网办在虹桥落地、创星食品案例）: https://www.shanghai.gov.cn/nw15343/20260825/7783833a86f741e48daa8fde70da7c0f.html
  • 东方财富网（2026-08-21）— 上海数字治理三连发（沪新跨境数字身份认证落地与2天拿证场景梳理）: https://caifuhao.eastmoney.com/news/20260821171248365276820
  • 上海市人民政府新闻发布 — 市政府新闻发布会问答实录（2026年9月3日，上海国际贸易中心”十五五”规划与外资便利化部署）: https://www.shanghai.gov.cn/nw9820/20260903/cfcb7a375569474796607ea6015fcd70.html

相关阅读

  • 见：外资企业注册时间线与电子执照（online-fie-registration-e-business-licence）
  • 见：一站式外资服务窗口及其覆盖（one-stop-fdi-service-windows）
Food & Beverage / 餐饮食品, Healthcare & Pharma / 医药医疗

China professionalises the hospital channel for medical-nutrition foods: the FSMP Guiding Opinions

  • In late August 2026, the National Health Commission (NHC) and SAMR jointly issued the Guiding Opinions on Regulating the Use of Foods for Special Medical Purposes (FSMP) in Medical Institutions (document 国卫办食品发〔2026〕11号, dated 6 August 2026).
    2026年8月下旬，国家卫生健康委办公厅与市场监管总局办公厅联合印发《关于规范医疗机构特殊医学用途配方食品使用的指导意见》（国卫办食品发〔2026〕11号，成文日期2026年8月6日），面向各级各类医疗机构。
  • The Opinions define FSMP as formula foods registered by SAMR for sale on the domestic market, formulated for people with restricted eating, digestive-absorption disorders, metabolic disorders or specific disease states, and require use under the guidance of a physician or clinical nutritionist.
    指导意见界定：特医食品是指经国家市场监管部门注册可以在国内市场销售、为满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要专门加工配制的配方食品，须在医师或临床营养技师指导下使用。
  • Medical institutions must set up a dedicated FSMP management department or group, maintain a dynamic internal supply catalogue admitting only SAMR-registered products, and centralise selection, procurement, use and charging.
    医疗机构须确立特医食品使用管理部门或小组，建立并动态调整本机构《特殊医学用途配方食品供应目录》，只允许经国家注册的特医食品进入目录，并对遴选、采购、使用、收费进行集中统一管理。
  • Within hospitals, FSMP must be sold in a clearly marked dedicated zone or counter (“特殊医学用途配方食品销售专区/专柜”), sale and usage information must be recorded and retained to medical-record standards, and FSMP must not be prescribed as medicine — it is not a drug, so no prescriptions, and billing must be separated from pharmaceuticals.
    院内管理上，特医食品须设专区专柜销售并显著提示；销售信息（含患者信息、品名、规格、价格）记录保存时限参照病历；特医食品不属于药品、不得开具处方，发放与收费须与药品区分。
  • For imported and domestic FSMP producers and their distributors, the guidance professionalises the hospital channel: registration status will be verified at the hospital gate, procurement and recall co-operation with institutions is formalised, and marketing into hospitals must shift from prescription-style promotion to compliance-based clinical-nutrition education.
    对国内外特医食品企业与经销商而言，新规使医院渠道走向专业化：注册资质在医院门口被核验，采购与召回配合被制度化，面向医院的推广须从”类处方”促销转向合规的临床营养教育。

China professionalises the hospital channel for medical-nutrition foods: the FSMP Guiding Opinions | 特医食品医院渠道走向规范化：两部门出台医疗机构使用指导意见

Overview

The National Health Commission (NHC) and the State Administration for Market Regulation (SAMR) jointly issued the Guiding Opinions on Regulating the Use of Foods for Special Medical Purposes (FSMP) in Medical Institutions (《关于规范医疗机构特殊医学用途配方食品使用的指导意见》) in late August 2026, with the document dated 6 August 2026 and publicised around 26–30 August. The Opinions, issued under the Food Safety Law and the Regulations on the Administration of Medical Institutions, apply to the selection, sale and use of FSMP within all types and levels of medical institutions in China. They mark the first time the national authorities have set out a complete operational framework for how hospitals should manage, stock, sell and use FSMP — a category that sits at the intersection of food, nutrition and clinical care.

What FSMP are — and why they need special rules

FSMP are formula foods that have been registered by SAMR for sale on the domestic market, specially processed and formulated to meet the nutritional or dietary needs of people with restricted eating, digestive or absorption disorders, metabolic disorders, or specific disease states. They provide important nutritional support for treatment, rehabilitation and maintenance of bodily function in these populations. Because they look like medical products but are legally food, they have historically sat in an ambiguous zone: food law governs their registration, yet their practical use is clinical, and hospitals have lacked uniform rules on procurement, pricing, storage and use.

The Opinions restate the fundamental boundary: FSMP must be used under the guidance of a physician or clinical nutritionist, and they are not drugs. The document applies to medical institutions holding a Medical Institution Practicing Licence or clinic-filing certificate.

Three layers of institutional rules

1. Governance structure. Each medical institution must establish a dedicated FSMP management department or group, build and dynamically adjust its own internal FSMP supply catalogue, verify product qualifications, and admit only FSMP registered by SAMR. The institution must set up rules for selection, review, procurement, use, periodic evaluation and exit, managing FSMP centrally and standardising the processes for receiving, using and charging.

2. In-hospital management systems. Institutions must take effective control measures across procurement, storage, sale and use; establish and refine systems for incoming-goods inspection and record-keeping (进货查验记录制度), warehouse management, in-and-out management, and handling of non-conforming FSMP; and designate personnel responsible for food-safety management. Practitioners involved in FSMP use — physicians or clinical nutritionists — should have clinical-nutrition education or training, plus FSMP-use knowledge and standardised-management training.

3. Clinical-use discipline. Practitioners should follow a standardised nutrition-diagnosis-and-treatment pathway, giving priority to dietary guidance and only proposing FSMP where dietary intervention cannot meet clinical needs and there are clinical indications. When recommending FSMP, they should explain the product’s details and its non-drug nature, whether alternative food or medicine exists, and obtain patient or family consent where used. FSMP use during a hospital stay should be recorded in the medical record, and the institution’s FSMP management department or group should evaluate the standardisation and reasonableness of use.

Selling and charging rules that matter commercially

Four operational rules are particularly important for producers and distributors:

  • Dedicated zone or counter. Institutions that sell FSMP must set up a separate sales area with a prominent sign reading “特殊医学用途配方食品销售专区（或专柜）”.
  • Record retention. Sales information — including patient information, FSMP name, specification and price — must be recorded and kept for a retention period consistent with medical records. This is a significant compliance consideration under the Personal Information Protection Law for patient-related data.
  • No prescriptions; separate billing. FSMP are not drugs, so they cannot be prescribed; their distribution and charging must be separated from pharmaceuticals. Institutions are encouraged to adopt information-system coding management that brings FSMP sales and use into hospital information systems.
  • No coercion. It is prohibited to sell or use, in the name of FSMP, any food that is not registered or that implies it can meet the special nutritional or dietary needs of the target populations. It is also prohibited to force or induce patients to buy FSMP in the institution or at designated outlets.

Recall co-operation

Institutions must co-operate with FSMP producers on recalls: once aware that a producer is recalling unsafe FSMP, the institution must immediately stop selling and seal the product and post a recall notice in a prominent position. Producers should therefore ensure their recall procedures reach hospital customers promptly and are documented.

What this means for producers and distributors

  • Registration is the admission ticket to the hospital channel. Hospitals may only list SAMR-registered FSMP in their supply catalogues. For importers, this reinforces the existing requirement to hold a Chinese registration for each product sold in China; products without registration cannot legally enter the hospital channel regardless of clinical demand.
  • The path to hospital formulary entry is now formal. Producers should expect hospital procurement to be run through the dedicated management group, with qualification review, and periodic re-evaluation. Building clinical-nutrition evidence and co-operation with nutrition departments — rather than prescription-oriented promotion — becomes the compliant route to market access.
  • Compliance burden moves down the chain. Distributors serving hospitals must ensure that labelling, storage and delivery meet the dedicated-zone and traceability expectations, and that patient-related sales data handling complies with privacy rules.
  • Regional variation is expected. The Opinions acknowledge that regions differ in economic development, medical-resource allocation and clinical-nutrition development, and encourage local implementation adapted to local conditions. Producers should track provincial implementation measures.
  • Opportunity in the nutritional-support gap. With an ageing population and growing awareness of clinical nutrition, FSMP remain a growth category; clearer rules that professionalise the hospital channel can favour compliant, well-evidenced brands — domestic and foreign alike.

Practical steps

  • Verify that every FSMP product marketed into China holds a valid SAMR registration matching the exact formula and label in use.
  • Prepare hospital-facing materials that support nutrition-department education and formulary review (clinical evidence summaries, usage guidance compliant with non-drug positioning).
  • Ensure recall plans include hospital customers and rapid notification mechanisms.
  • Review distributor agreements for compliance with dedicated-zone sale, record-retention and no-coercion rules.
  • Monitor provincial implementation guidance and adjust sales models per region.

Sources

  • 市场监管总局 — 国家卫生健康委办公厅 市场监管总局办公厅关于规范医疗机构特殊医学用途配方食品使用的指导意见（全文）: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2026/art_81290de7385d4573939b6790103a5fb1.html
  • 市场监管总局（新闻）— 两部门联合出台指导意见 规范医疗机构使用特殊医学用途配方食品: https://www.samr.gov.cn:8007/xw/zj/art/2026/art_b34e6b283ecf4530a93aef63c6194e9f.html
  • 毕节市人民政府（政策解读转载）— 划红线、建目录、禁开处方！国家出台新规规范特医食品使用: https://www.bijie.gov.cn/bm/bjswsjkj/zwgk/zcwjjjd/202608/t20260831_90801118.html
  • 人民网湖北频道 — 国家卫生健康委等规范医疗机构特医食品使用管理: https://hb.people.com.cn/n2/2026/0831/c192237-41681914.html

Related reading

  • see also: China’s FSMP registration regime — the 2024 Administrative Measures baseline (fsmp-registration-measures)
  • see also: medical-device and pharma market entry routes into Chinese hospitals (healthcare-market-access)

特医食品医院渠道走向规范化：两部门出台医疗机构使用指导意见

概述

2026年8月下旬，国家卫生健康委办公厅与市场监管总局办公厅联合印发《关于规范医疗机构特殊医学用途配方食品使用的指导意见》（成文日期2026年8月6日，8月26日前后对外发布）。指导意见依据《食品安全法》《医疗机构管理条例》等法律法规制定，适用于各级各类医疗机构内特医食品的遴选、销售与使用，是国家层面首次为医院如何管理、采购、销售和使用特医食品建立完整操作框架。特医食品正处于食品、营养与临床照护的交叉地带，此前的管理长期存在模糊区。

什么是特医食品——以及为何需要专门规则

特医食品是指经国家市场监管部门注册可以在国内市场销售，为满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要，专门加工配制而成的配方食品。对这些人群的治疗、康复及机体功能维持起着重要营养支持作用。它看起来像医疗产品、法律上却是食品：注册环节适用食品法，实际使用却是临床行为，医院在采购、定价、储存与使用上长期缺乏统一规则。

指导意见重申根本边界：特医食品须在医师或临床营养技师指导下使用，且不属于药品。文件适用于持有《医疗机构执业许可证》或诊所备案凭证、依法从事疾病诊断和治疗活动的诊疗机构。

三层制度要求

一、治理架构。 医疗机构须确立特医食品使用管理部门或小组，建立并动态调整本机构《特殊医学用途配方食品供应目录》，审核产品资质，只允许经国家市场监管部门注册的特医食品进入目录。医院要建立遴选、审核、采购、使用、定期评估和退出制度，对特医食品集中统一管理，规范领取、使用与收费流程。

二、院内管理制度。 医院须在采购、贮存、销售及使用等环节采取有效控制措施，建立健全进货查验记录制度、仓储场所管理制度、出入库管理制度及不合格特医食品处置制度，明确负责食品安全管理的人员。从事特医食品使用工作的医师或临床营养技师等，应经过临床营养专业教育或培训，以及特医食品使用知识和规范化管理培训。

三、临床使用规范。 医师或临床营养技师应严格遵照规范化营养诊疗流程，优先提出膳食指导建议；膳食干预无法满足临床需求时，方可根据临床应用指征提出必要的特医食品使用建议。提出建议时应说明食品详情和非药品属性、是否有可替代的食品或药品，使用应征得患者或家属同意。患者住院期间使用特医食品的情况应记入病历，医院特医食品使用管理部门或小组应组织评估使用规范性与合理性。

对商业运营至关重要的销售与收费规则

以下四项操作性规则对生产企业和经销商尤其关键：

  • 专区专柜。 医疗机构经营特医食品，应设专门的销售区域，显著位置设提示牌，注明”特殊医学用途配方食品销售专区（或专柜）”字样。
  • 信息留存。 对销售信息（含患者信息、特医食品名称、规格、价格）进行记录和保存，保存时限参照病历。涉及患者信息的数据处理须同时符合《个人信息保护法》等要求。
  • 不得开处方、收费分离。 特医食品不属于药品、不得开具处方，其发放、收费等应当与药品区分；鼓励有条件的机构做好信息业务编码管理，将特医食品销售和使用项目纳入院内信息系统。
  • 禁止强制销售。 严禁以特医食品名义销售或使用未经国家注册批准、明示或暗示可用于满足目标人群特殊营养或膳食需要的食品；严禁强制或诱导患者在本机构或到指定地点购买。

召回配合

医疗机构应配合特医食品生产企业开展召回：一旦知悉企业召回不安全特医食品，应立即停止销售并封存、在醒目位置张贴召回公告。生产企业应确保召回程序能及时触达医院客户并留存记录。

对企业与经销商的意义

  • 注册资质是进入医院渠道的门票。 医院目录只接纳经国家注册的特医食品。进口商须为在华销售的每个产品持有有效中国注册证；无注册证的产品无论临床需求多大都无法合法进入医院渠道。
  • 进入院内目录的路径正式化。 生产企业应预期采购由专门管理小组按资质审核与定期再评估流程运作。建立临床营养证据、与营养科开展合规合作，而非”类处方”式促销，成为合规的市场准入路径。
  • 合规压力沿渠道下移。 服务医院的经销商须确保标签、储存与配送满足专区与可追溯预期，涉患者销售数据的处理符合隐私规则。
  • 地区差异可期。 指导意见承认各地在经济发展水平、医疗资源配置与临床营养学科建设上存在差异，鼓励各地结合本地实际实施。企业应跟踪省级落实细则。
  • 营养支持缺口中的机遇。 在人口老龄化与临床营养意识提升背景下，特医食品仍是增长品类；医院渠道专业化的清晰规则，将有利于合规、有证据的国内外品牌。

实务建议

  • 核验在华销售的每个特医食品产品均持有与在用配方、标签一致的有效的国家注册证。
  • 准备面向医院的合规材料，支持营养科教育与目录评审（临床证据摘要、符合非药品定位的使用指引）。
  • 确保召回计划覆盖医院客户并具备快速通知机制。
  • 审查经销商协议，确保其遵守专区销售、记录留存与禁止强制销售规则。
  • 跟踪各省级实施指引，分区域调整销售模式。

来源

  • 市场监管总局 — 国家卫生健康委办公厅 市场监管总局办公厅关于规范医疗机构特殊医学用途配方食品使用的指导意见（全文）: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2026/art_81290de7385d4573939b6790103a5fb1.html
  • 市场监管总局（新闻）— 两部门联合出台指导意见 规范医疗机构使用特殊医学用途配方食品: https://www.samr.gov.cn:8007/xw/zj/art/2026/art_b34e6b283ecf4530a93aef63c6194e9f.html
  • 毕节市人民政府（政策解读转载）— 划红线、建目录、禁开处方！国家出台新规规范特医食品使用: https://www.bijie.gov.cn/bm/bjswsjkj/zwgk/zcwjjjd/202608/t20260831_90801118.html
  • 人民网湖北频道 — 国家卫生健康委等规范医疗机构特医食品使用管理: https://hb.people.com.cn/n2/2026/0831/c192237-41681914.html

相关阅读

  • 见：中国特医食品注册管理——《注册管理办法》（2024年施行）基线（fsmp-registration-measures）
  • 见：药品与医疗器械进入中国医院市场的路径（healthcare-market-access）
Automotive & EV / 汽车新能源

China’s one-year vehicle production-consistency and quality campaign: what it means for automakers and suppliers

  • On 27 August 2026, the Ministry of Industry and Information Technology (MIIT), the Ministry of Public Security, the Ministry of Ecology and Environment and SAMR jointly launched a one-year special campaign on production consistency and quality improvement for road motor vehicles (document MIIT Office letter 联通装函〔2026〕407号, dated 21 August 2026).
    2026年8月27日，工业和信息化部、公安部、生态环境部、市场监管总局四部门联合发布通知，自即日起在全国开展为期一年的道路机动车辆产品生产一致性和质量提升专项行动（文号：工信厅联通装函〔2026〕407号，落款日期2026年8月21日）。
  • The campaign targets four problem areas: production consistency (量产车参数与《公告》一致性), reliability, durability and test verification of new technologies, in an effort to steer the intensely price-competitive NEV market back towards quality and technology.
    专项行动集中整治四方面问题：生产一致性、可靠性、耐久性与新技术测试验证，意在把竞争激烈的新能源汽车市场引导回”质量与技术”赛道。
  • Production consistency checks cover three layers: whether mass-produced vehicles match the parameters and mandatory national standards in the vehicle Public Announcement; how OEMs manage component suppliers (procurement standards, incoming inspection, parts quality); and the OEM’s consistency-assurance capability (personnel, equipment, processes, management systems).
    生产一致性检查覆盖三个层面：量产车技术指标与《道路机动车辆生产企业及产品公告》参数及国家标准的一致性；整车企业对零部件供应商的管理（采购标准、进货检验、零部件质量）；整车企业生产一致性保证能力（人员、设备、工艺、管理体系）。
  • Verification of new technologies now extends to intelligent-connected vehicles and AI: driving-assistance and autonomous-driving functions must be sufficiently tested and validated, product and cloud-platform data and network security protections must be adequate, and logs for incident investigation must be complete.
    新技术测试验证延伸到智能网联与人工智能：组合驾驶辅助及自动驾驶功能须充分测试验证，产品与云端平台的数据安全、网络安全防护须充分，用于案事件调查的日志留存须完整。
  • For foreign brands manufacturing in China and global suppliers to Chinese OEMs, the campaign signals stricter enforcement of the “公告准入—一致性保持—质量责任” chain and deeper scrutiny of the supply chain; quality consistency work that used to be paperwork-heavy now faces real verification against samples and test data.
    对在华生产的外资品牌与供应中国主机厂的全球零部件企业而言，专项行动意味着”公告准入—一致性保持—质量责任”链条执法收紧、供应链穿透式检查加深；过去偏重纸面材料的一致性工作将面临样车抽检与试验数据的实地核验。

China’s one-year vehicle production-consistency and quality campaign: what it means for automakers and suppliers | 四部门启动为期一年的机动车生产一致性与质量提升专项行动

Overview

On 27 August 2026, four Chinese authorities — the Ministry of Industry and Information Technology (MIIT), the Ministry of Public Security, the Ministry of Ecology and Environment and the State Administration for Market Regulation (SAMR) — jointly published the Notice on Launching a Special Campaign on Production Consistency and Quality Improvement for Road Motor Vehicles (关于开展道路机动车辆产品生产一致性和质量提升专项行动的通知, 工信厅联通装函〔2026〕407号). The campaign runs nationwide for one year from the date of issue and follows a 17 July 2026 meeting at which MIIT’s Equipment Industry Department I asked major automakers to strengthen self-inspection, and unannounced consistency inspections at OEMs including GAC Aion, Xpeng, Chery, NIO and JAC during July.

The campaign’s stated purpose is to regulate the competitive order of the new-energy-vehicle (NEV) industry and hold the line on production consistency and quality safety. Coming after a period of aggressive price competition in China’s NEV market, the initiative is widely read by analysts as a signal that competition must return to quality and technology rather than price and speed.

The four problem areas under scrutiny

1. Production consistency (生产一致性). This is the first and deepest target. Inspections verify:

  • whether mass-produced vehicles’ technical parameters match the vehicle Public Announcement (《公告》) and comply with relevant mandatory national standards;
  • how the OEM manages component suppliers — procurement standards, incoming inspection and parts-quality management;
  • whether the OEM has a genuine consistency-assurance capability: personnel competence, production and inspection equipment, purchased raw materials and parts assemblies and their suppliers, production processes, working environment and management systems.

MIIT’s Equipment Industry Development Centre describes production consistency as the baseline institutional requirement of vehicle admission management: the parameters, configurations and performance of batch-produced vehicles must remain consistent with the type-approved product, the type-test sample and the certificate information, and continue to meet mandatory national standards. On 28 August 2026, MIIT published typical cases from the 2025 NEV production-consistency supervision and inspection, including sample vehicles delivered without user manuals, individual parameters inconsistent with the Announcement, and emergency-window net areas and side/rear underrun-protection performance failing national-standard requirements.

2. Reliability (可靠性). Checks cover the reliability testing and validation of complete vehicles, key systems and components, and whether manufacturing processes and standards at OEMs and parts makers can guarantee reliability.

3. Durability (耐久性). Inspectors look at new-vehicle design service life and R&D cycles, body-material selection, anti-corrosion processes and structural protection, and recorded problems such as defects, corrosion and suspension fractures.

4. Test verification of new technologies (新技术测试验证). This category is squarely aimed at the intelligent-connected era:

  • whether innovative designs adequately assess risks to user habits, misuse and extreme-use scenarios, and whether marketing claims match reality;
  • whether new materials and structures carry hidden defect or fatigue-failure risks;
  • whether combined driving-assistance and autonomous-driving functions have been sufficiently tested and validated; whether product and cloud-platform data-security and network-security protections are adequate; whether AI-safety protections are adequate; whether security measures were planned, built and put into use simultaneously (“三同步”); and whether logs needed for incident investigation are complete.

The campaign also calls for establishing industry-wide third-party testing and evaluation activity guidelines that are standardised, open, fair and traceable, continued crackdowns on exaggerated and false advertising, and public disclosure of problem enterprises and inspection bodies to draw clear “red lines”.

How the campaign is enforced

The Notice asks provincial industry-and-information-technology, public-security, ecology-and-environment and market-regulation departments to implement it in their localities under territorial responsibility, strictly regulate administrative inspections of enterprises, and report results to the four ministries after the year ends. An annex sets out a work plan for inspecting manufacturers’ product-safety-assurance capability and production consistency.

Key expectations are placed on:

  • Vehicle manufacturers: strengthen their primary responsibility for production consistency and quality safety, conduct deep self-inspection and correction, resist irrational competition, tighten supply-chain management, strengthen consistency-assurance capability, improve testing and validation of new products, standardise marketing claims, and hold the product-safety line.
  • Inspection and testing institutions: operate lawfully, impartially and objectively, and genuinely improve work quality.
  • Industry associations: guide self-discipline and corporate social responsibility.
  • Standardisation bodies: accelerate the drafting and revision of relevant standards.
  • Technical-service institutions: strictly conduct technical review, including assessment of innovative designs.

What this means for foreign-invested players

  • Localised manufacturers under sharper scrutiny. Foreign brands producing NEVs in China — whether through wholly owned plants or joint ventures — must verify that mass-production data, supplier records and certification documents align with the Announcement for every model sold. Discrepancies that previously triggered warnings may now produce public naming and penalties.
  • Suppliers drawn into the inspection web. Because consistency checks reach into procurement standards and incoming inspection, component suppliers (batteries, motors, electronics, chassis) will face more demanding customer audits and possibly direct regulatory contact. Global suppliers should expect OEM requests for higher documentation standards and tighter quality agreements.
  • The intelligent-driving agenda is now a compliance topic. With AI and autonomous-driving functions inside the test-verification scope, software-defined vehicle makers and their algorithm/data partners must demonstrate adequate testing, cybersecurity and data-protection measures, and complete log retention. This aligns with the mandatory national standards for intelligent-connected vehicles (e.g. GB 44721—2026 and GB 47955—2026, published 2026) that set a framework for safe operation of the technology.
  • Marketing claims need a legal scrub. The campaign’s emphasis on curbing exaggerated and false advertising means sales and PR materials making performance, range or safety claims should be reviewed against verified test data.

Practical steps

  • Run an internal consistency audit: compare current production configuration, software versions and component part numbers against the Announcement and certification files for each model.
  • Tighten supplier quality management: verify incoming-inspection records, and ask key suppliers to confirm their own consistency controls.
  • Strengthen test-verification documentation for ADAS/AD features, including cybersecurity reviews of vehicle and cloud platforms and log-retention arrangements.
  • Prepare for potential on-site inspection and sample testing; designate a responsible officer for campaign-related queries from local authorities.
  • Review advertising and marketing materials for consistency with verified technical data before publication.

Sources

  • 工信部装备工业发展中心 — 工业和信息化部等四部门办公厅关于开展道路机动车辆产品生产一致性和质量提升专项行动的通知（全文）: https://www.miit-eidc.org.cn/art/2026/8/27/art_1657_12693.html
  • 工信微报（网易转载）— 四部门联合整治汽车质量 推动行业竞争回归质量与技术: https://www.163.com/dy/article/L5IO290I0514K35E.html
  • 央视新闻（今日头条转载）— 四部门开展专项行动集中整治车辆可靠性耐久性等问题: https://www.toutiao.com/article/7678641260592103986

Related reading

  • see also: NEV 15th Five-Year Plan signals — where the sector is heading (341-nev-fifteenth-fyp)
  • see also: China’s mandatory national standards for intelligent-connected vehicles (intelligent-connected-vehicle-gb-standards)

四部门启动为期一年的机动车生产一致性与质量提升专项行动

概述

2026年8月27日，工业和信息化部、公安部、生态环境部、市场监管总局联合发布《关于开展道路机动车辆产品生产一致性和质量提升专项行动的通知》（工信厅联通装函〔2026〕407号，落款日期2026年8月21日），宣布自即日起在全国范围内开展为期一年的专项行动。此前的7月17日，工信部装备工业一司已召开重点汽车生产企业座谈会部署自查；7月下旬又对广汽埃安、小鹏、奇瑞、蔚来、江淮等企业开展产品安全保障能力和生产一致性监督检查。

专项行动旨在规范新能源汽车产业竞争秩序、守牢产品生产一致性和质量安全底线。在经历一轮激烈价格战之后，业内普遍将其解读为：竞争必须回到质量与技术，而不是价格与速度。

重点整治的四个方面

一、生产一致性。 这是排在第一位的深度整治对象，检查涵盖三方面：

  • 整车企业量产车技术指标与《道路机动车辆生产企业及产品公告》参数的一致性、相关国家标准的符合性；
  • 整车企业对零部件供应商的管理情况——采购标准、进货检验、零部件产品质量管理；
  • 整车企业的生产一致性保证能力——人员能力、生产与检验设备、采购的原材料和零部件总成及其供应商、生产工艺、工作环境、管理体系。

工信部装备工业发展中心将生产一致性概括为机动车准入管理的基础制度要求：企业批量生产销售车辆的技术参数、配置、性能，要与《公告》型式批准的产品、型式试验样品、合格证信息保持一致，持续符合国家强制性标准。8月28日，工信部公开曝光2025年度新能源汽车产品生产一致性监督检查典型案例，包括样车未配说明书、个别参数与《公告》不一致、应急窗净面积与侧后防护装置性能不符合国标要求等。

二、可靠性。 检查整车产品、关键系统和零部件的可靠性测试验证情况，以及整车与零部件企业生产制造工艺标准能否保证产品可靠性。

三、耐久性。 检查整车企业新车设计使用寿命和研发周期、车身材料选用、防腐工艺、结构防护要求，以及产品缺陷、锈蚀、悬架断裂等问题。

四、新技术测试验证。 这一项直接指向智能网联时代：

  • 新产品创新设计对用户习惯、误操作风险、极端使用场景的风险评估是否充分，营销宣传是否符合实际；
  • 新材料、新结构是否存在产品缺陷、疲劳失效等风险隐患；
  • 组合驾驶辅助及自动驾驶功能测试验证是否充分；产品及云端平台数据安全、网络安全防护是否充分；人工智能安全防护是否充分；是否同步规划、同步建设、同步使用；用于案事件调查的日志留存是否完整。

专项行动还要求研究建立规范、公开、公正、可追溯的汽车行业第三方测评活动指南，持续整治汽车行业网络乱象、严厉打击夸大和虚假宣传，公开通报问题企业与检验机构，为行业划清”红线”、守牢”底线”。

如何执行

通知要求各地工信、公安、生态环境、市场监管部门落实属地责任，开展本地区专项行动，严格规范涉企行政检查，一年期满后向四部门报送工作情况。附件为《道路机动车辆生产企业产品安全保障能力和生产一致性监督检查工作方案》。

各环节责任被明确压实：整车企业要深入开展自查自纠、自觉抵制非理性竞争、加强供应链管理、强化生产一致性保证能力、加强新产品测试验证、规范营销宣传；检验检测机构要依法依规公正客观执业；行业协会引导自律；标准化组织加快标准制修订；技术服务机构严格技术审查并加强对创新设计的审查评估。

对外资车企与供应商的意义

  • 本土化生产的外资品牌面临更严核验。 无论独资还是合资，外资新能源品牌必须确保每个在售车型的量产数据、供应商记录与认证文件同《公告》一致。以往可能只是警示的偏差，如今可能被公开点名并处罚。
  • 供应商被纳入穿透式检查网。 一致性检查深入采购标准与进货检验，电池、电机、电控、底盘等零部件供应商将面对更严苛的客户审核，甚至监管部门的直接接触。全球供应商应预期主机厂提出更高的文件化标准和更严的质量协议。
  • 智能驾驶议题成为合规议题。 自动驾驶与人工智能功能进入测试验证范围，软件定义汽车厂商及其算法、数据合作伙伴必须证明测试充分、网安与数据保护到位、日志留存完整。这与2026年发布的多项智能网联汽车强制性国家标准（如GB 44721—2026、GB 47955—2026）相衔接，共同为技术安全运行划定框架。
  • 营销话术需要法务审查。 专项行动强调遏制夸大与虚假宣传，销售与公关材料中的性能、续航、安全类表述应与经核验的试验数据一致。

实务建议

  • 开展内部一致性审计：逐车型核对量产配置、软件版本与零部件号是否与《公告》和认证文件一致。
  • 收紧供应商质量管理：核查进货检验记录，要求关键供应商确认其自身一致性管控。
  • 完善ADAS/AD功能测试验证文档，包括车端与云端平台的网络安全审查与日志留存安排。
  • 为可能的现场检查与样车抽检做准备，指定专人对接地方主管部门在行动期间的问询。
  • 发布前审查广告与营销材料的各项表述是否与已核验技术数据一致。

来源

  • 工信部装备工业发展中心 — 四部门办公厅关于开展道路机动车辆产品生产一致性和质量提升专项行动的通知（全文）: https://www.miit-eidc.org.cn/art/2026/8/27/art_1657_12693.html
  • 工信微报（网易转载）— 四部门联合整治汽车质量 推动行业竞争回归质量与技术: https://www.163.com/dy/article/L5IO290I0514K35E.html
  • 央视新闻（今日头条转载）— 四部门开展专项行动集中整治车辆可靠性耐久性等问题: https://www.toutiao.com/article/7678641260592103986

相关阅读

  • 见：新能源汽车”十五五”政策信号——产业走向何方（341-nev-fifteenth-fyp）
  • 见：中国智能网联汽车强制性国家标准（intelligent-connected-vehicle-gb-standards）
Education & Training / 教育培训

Fujian’s “15th Five-Year Plan” education blueprint opens the door wider for Sino-foreign cooperative education

  • On 24 August 2026, the Fujian provincial government printed and distributed the Fujian “15th Five-Year Plan” Education Development Plan (闽政〔2026〕24号), setting the 2030 goal that a strong-education-province foundation is further consolidated and a high-quality education system is basically completed.
    2026年8月24日，福建省人民政府印发《福建省”十五五”教育发展规划》（闽政〔2026〕24号），提出到2030年教育强省建设基础进一步夯实、高质量教育体系基本建成的目标。
  • The Plan explicitly supports localities and universities in introducing world-renowned universities to run Sino-foreign cooperative education institutions and programmes in Fujian, focusing on urgently needed, science-engineering-agriculture-medicine and cross-disciplinary frontier subjects, and supports Tianjin University’s Fuzhou International Joint College in establishing further cooperative institutions and programmes.
    规划明确”鼓励境外高水平大学来闽设立中外合作办学机构和项目”，支持各地和高校引进世界知名大学，聚焦急需紧缺、理工农医、交叉前沿学科举办中外合作办学机构和项目；支持天津大学福州国际联合学院设立若干中外合作办学机构和项目。
  • A dedicated “Sino-Foreign Cooperative Education Support Plan” is listed as a major project in the Plan’s special column on cross-strait education integration and high-level opening-up, alongside the “Future Maritime Silk Road Excellent Partners” plan and an “International Chinese Education Leading” plan.
    规划在”推动闽台教育融合发展和教育高水平开放合作重大工程”专栏单列”中外合作办学支持计划”，与”未来海丝卓越伙伴”计划、”国际中文教育领航”计划并列。
  • For Hong Kong and Macao institutions, the Plan promises support for high-quality higher-education resources from Hong Kong and Macao to land in Fujian and for joint talent-training programmes between Fujian and Hong Kong/Macao universities.
    对港澳高校，规划提出”支持港澳优质高等教育资源落地福建，推进闽港澳高校人才联合培养项目”，并常态化开展闽港澳中小学姊妹校交流。
  • For foreign universities and education investors, the Plan is a concrete provincial invitation: Fujian pairs its manufacturing and maritime economy with international higher education, opening a window for brand-name universities to enter through Fuzhou, Xiamen and the Pingtan experimental zone under China’s existing Sino-foreign cooperative education regulatory framework.
    对外国大学与教育投资者而言，这是一份具体的省级邀请函：福建把制造业与海洋经济同国际高等教育对接，为知名大学在中国现有中外合作办学监管框架下经福州、厦门及平潭试验区进入提供了窗口。

Fujian’s “15th Five-Year Plan” education blueprint opens the door wider for Sino-foreign cooperative education | 福建”十五五”教育规划：中外合作办学的大门开得更宽

Overview

On 24 August 2026, the Fujian provincial government printed and distributed the Fujian “15th Five-Year Plan” Education Development Plan (《福建省”十五五”教育发展规划》, 闽政〔2026〕24号). Drafted under the national Education Development “15th Five-Year Plan” and Fujian’s own 15th Five-Year economic-and-social plan, the document sets the 2030 goal that the foundation for building Fujian into a strong education province is further consolidated and a high-quality education system is basically completed. For international education providers, the parts that matter most sit in the sections on deepening cross-strait education integration and raising the level of international opening-up in education.

Development goals for 2030

The Plan sets out targets including: pre-school three-year enrolment maintained above 99.5 per cent and public-kindergarten share above 65 per cent; nine-year compulsory-education consolidation kept above 99 per cent; and an explicit ambition that the level of Sino-foreign cooperative education rises markedly and Fujian’s education influence continues to expand. Higher education is expected to restructure its types, levels and layout, with discipline structures increasingly matched to the province’s modern industrial clusters and future industries — the context in which international partners are invited in.

The four tracks of education opening-up

The Plan organises Fujian’s international education agenda under four major projects in a special column on “Promoting the Integrated Development of Fujian-Taiwan Education and High-Level Opening-up of Education”:

1. Fujian-Taiwan education integration project (闽台教育融合发展工程). Universities are supported in recruiting students from Taiwan through multiple channels; single-recruitment for Taiwan students is to be expanded to all public undergraduate universities and quality higher-vocational colleges; high-quality Taiwan higher-education resources are to be introduced for cooperative education in Fujian; and Fujian-Taiwan characteristic discipline clusters and high-level research and innovation platforms are to be co-built.

2. Sino-foreign cooperative education support plan (中外合作办学支持计划). The Plan supports localities and universities in introducing world-renowned universities to establish Sino-foreign cooperative education institutions and programmes in Fujian, concentrating on disciplines that are urgently needed, aligned with national strategy and regional development, spanning science, engineering, agriculture and medicine, and at the frontier of cross-disciplinary fields. It also supports Tianjin University Fuzhou International Joint College in establishing a number of cooperative education institutions and programmes. The existing college — a milestone project between Tianjin University and the city of Fuzhou — is treated as a platform to be scaled rather than a one-off.

3. “Future Maritime Silk Road Excellent Partners” plan (未来海丝卓越伙伴计划). Fujian will keep building the “21st Century Maritime Silk Road” university alliance, improve the Chinese-foreign dual-supervisor talent-cultivation mechanism, advance international industry-university-research co-operation, deepen the “Study in Fujian — Excellent International Summer School” programme, and expand exchanges with universities, research institutes and enterprises in friendly provinces, states and sister cities.

4. “International Chinese Education Leading” plan (国际中文教育领航计划). Fujian will strengthen its international Chinese education and study-in-China alliances, support universities in building smart Chinese-learning platforms and localised teaching resources, promote the transformation of Confucius Institutes towards “language services + professional domains”, and co-ordinate international Chinese education with overseas Chinese-language education.

Alongside these four projects, the Plan separately commits to bringing Hong Kong and Macao into the picture: “support high-quality higher-education resources from Hong Kong and Macao to land in Fujian, advance Fujian-Hong Kong/Macao joint talent-training projects at universities”, expand teacher visits to Hong Kong and Macao for study and research, and routinise sister-school exchanges between Fujian and Hong Kong/Macao primary and secondary schools.

Regulatory context for foreign entrants

Sino-foreign cooperative education in China operates under the Regulations on Sino-Foreign Cooperative Education (2003) and its implementation rules, administered by the Ministry of Education at the national level for institution-establishment, with programme-level approvals also handled by provincial education departments within delegated authority. Fujian’s Plan does not change the national framework; it signals provincial demand and prioritisation — a necessary ingredient for a successful application, since provincial recommendation and support materially smooth the approval process. The Tianjin University Fuzhou International Joint College precedent shows the “famous Chinese university + overseas partner” or “Chinese university-led, overseas partner-in” model that the province prefers to scale.

What this means for foreign universities and investors

  • A provincial-level demand signal. Provinces compete to attract top international education brands; Fujian has now written Sino-foreign cooperative education expansion into its statutory five-year plan, with an explicit support plan and named platform (Tianjin University Fuzhou International Joint College). Foreign universities evaluating a China campus should treat Fujian as an actively recruiting destination.
  • Discipline focus is defined. Needed fields are “urgently needed, aligned with national strategy and regional development, science-engineering-agriculture-medicine and cross-disciplinary frontier”. Maritime, new-energy, digital-economy, healthcare and advanced-manufacturing-linked programmes are natural fits given Fujian’s industrial base.
  • The “university-led” platform model is favoured. Rather than brand-new greenfield campuses alone, the province favours established Chinese universities (e.g. Tianjin University in Fuzhou) adding overseas partners and programmes — a lower-risk entry model for foreign institutions than sole establishment.
  • Hong Kong and Macao universities have a fast lane. The explicit commitment to Hong Kong/Macao higher-education resources and joint programmes reflects the Greater Bay Area-style deepening of cross-border education co-operation and gives Hong Kong and Macao institutions a clearly articulated provincial invitation.
  • Taiwan-channel caution. Foreign institutions should be mindful that Fujian’s Taiwan-facing education agenda operates within the relevant cross-strait arrangements; for non-Chinese universities, the main practical relevance is the province’s overall openness posture and its competition for international partners.

Practical steps

  • For universities considering a China campus: engage the Fujian provincial education department early to test feasibility, and review the Tianjin University Fuzhou International Joint College model as a template.
  • Identify a Chinese university partner with complementary strengths; Sino-foreign cooperative education institutions require a Chinese partner institution by regulation.
  • Align proposed disciplines with Fujian’s industrial clusters (maritime economy, advanced manufacturing, digital economy, healthcare) to strengthen the provincial-support case.
  • For programme-level entry, confirm whether the intended programme requires Ministry of Education or provincial approval and prepare the feasibility, curriculum, faculty and quality-assurance documents accordingly.
  • Monitor Fujian’s implementation measures and any provincial catalogue or application guidance that follows the Plan during late 2026.

Sources

  • 福建省人民政府 — 关于印发《福建省”十五五”教育发展规划》的通知（闽政〔2026〕24号，全文）: https://www.fujian.gov.cn/zwgk/zxwj/szfwj/202608/t20260828_7206084.htm
  • 福建省人民政府 — 《福建省”十五五”教育发展规划》政策解读: https://fujian.gov.cn/jdhy/zcjd/202608/t20260828_7206086.htm
  • 福州新闻网 — 福建印发”十五五”教育发展规划 到2030年普高招生计划比例力争达八成: https://news.fznews.com.cn/dsxw/20260830/6a9384b95dc47.shtml

Related reading

  • see also: how foreign universities enter China — Sino-foreign cooperative education pathways (sino-foreign-cooperative-education-pathways)
  • see also: Hainan’s international education island experiment (356-hainan-international-education)

福建”十五五”教育规划：中外合作办学的大门开得更宽

概述

2026年8月24日，福建省人民政府印发《福建省”十五五”教育发展规划》（闽政〔2026〕24号）。规划依据国家《教育发展”十五五”规划》与《福建省国民经济和社会发展第十五个五年规划纲要》制定，提出到2030年教育强省建设基础进一步夯实、高质量教育体系基本建成的目标。对国际教育机构而言，最值得关注的内容集中在”深化闽台教育融合发展、提升国际教育开放合作水平”部分。

2030年发展目标

规划提出的目标包括：学前三年入园率保持在99.5%以上、公办园在园幼儿占比达到65%以上；九年义务教育巩固率保持在99%以上；并明确提出中外合作办学层次明显提升、福建教育影响力持续扩大。高等教育要在类型、层次、布局上持续优化，学科专业结构与全省现代化产业集群和未来产业体系更加适配——这正是邀请国际伙伴进入的背景。

教育对外开放的四条跑道

规划在”推动闽台教育融合发展和教育高水平开放合作重大工程”专栏下，用四个重大工程组织福建的国际教育议程：

一、闽台教育融合发展工程。 支持高校多渠道开展对台招生，推动对台单招扩大至全省公办本科高校及优质高职院校；引进台湾优质高等教育资源来闽合作办学，共建闽台特色专业群和高水平科研创新平台。

二、中外合作办学支持计划。 规划”支持各地和高校引进世界知名大学，聚焦符合国家战略和区域发展的急需紧缺、理工农医、交叉前沿的学科专业，来闽举办中外合作办学机构和项目”，并”支持天津大学福州国际联合学院设立若干中外合作办学机构和项目”。这所天津大学与福州市共建的标志性学院被当作可放大的平台，而非一次性项目。

三、”未来海丝卓越伙伴”计划。 持续建设”21世纪海上丝绸之路”大学联盟，完善中外双导师育人机制，推进国际产学研用合作，深入实施”留学福建—卓越国际暑校”项目，深化与友好省州友城所在国高校、科研院所和企业的交流合作。

四、”国际中文教育领航”计划。 加强”福建省国际中文教育暨来华留学联盟”等建设，支持高校打造中文智慧学习平台、开发本土化教学资源，推动孔子学院向”语言服务+专业领域”高质量发展，推动国际中文教育与海外华文教育协同发展。

在这四个项目之外，规划把港澳单独写入：“支持港澳优质高等教育资源落地福建，推进闽港澳高校人才联合培养项目”，加大骨干教师赴港澳访学研修选派力度，常态化开展闽港澳中小学姊妹校交流。

外资进入的监管背景

中国的中外合作办学适用《中外合作办学条例》（2003年）及其实施办法：设立机构由教育部在国家层面审批，项目层面在授权范围内也由省级教育部门办理。福建规划不改变国家框架，它释放的是省级需求与优先级信号——这是申请成功的关键要素之一，因为省级推荐与支持能实质性地畅通审批流程。天津大学福州国际联合学院的先例说明，福建偏好放大”国内名校牵头、海外伙伴加入”的模式。

对外国大学与投资者的意义

  • 省级需求信号明确。 各省都在争抢顶级国际教育品牌；福建已把扩大中外合作办学写入法定五年规划，并配以专门支持计划和具名平台（天津大学福州国际联合学院）。评估中国校区的海外大学，应把福建视为积极招引的目的地。
  • 学科方向已划定。 急需紧缺、服务国家战略与区域发展、理工农医、交叉前沿是关键词。结合福建产业基础，海洋、新能源、数字经济、医疗健康与先进制造相关专业天然契合。
  • 偏好”名校牵头”平台模式。 相比纯新建校园，福建更青睐既有国内高校（如福州的天大联合学院）叠加海外伙伴与项目——对外国院校而言，这是比独立设校风险更低的进入模式。
  • 港澳高校有快车道。 对港澳高等教育资源与联合培养项目的明确承诺，呼应大湾区式跨境教育合作深化，为港澳院校提供了清晰的省级邀请。
  • 涉台渠道需注意边界。 外国机构应注意，福建对台教育议程在相关两岸安排框架内运作；对非中国大学而言，主要实际意义在于福建整体开放姿态及其对国际伙伴的竞争。

实务建议

  • 考虑在华设校的大学：尽早对接福建省教育厅测试可行性，研究天津大学福州国际联合学院模式作为模板。
  • 寻找学科互补的中国合作高校——依条例中外合作办学机构必须有中国合作方。
  • 使拟设学科对接福建产业集群（海洋经济、先进制造、数字经济、医疗健康），以强化省级支持论证。
  • 项目级进入时，确认拟办项目需教育部还是省级审批，并据此准备可行性、课程、师资与质量保障材料。
  • 跟踪福建实施办法及2026年下半年规划后续出台的省级目录或申报指引。

来源

  • 福建省人民政府 — 关于印发《福建省”十五五”教育发展规划》的通知（闽政〔2026〕24号，全文）: https://www.fujian.gov.cn/zwgk/zxwj/szfwj/202608/t20260828_7206084.htm
  • 福建省人民政府 — 《福建省”十五五”教育发展规划》政策解读: https://fujian.gov.cn/jdhy/zcjd/202608/t20260828_7206086.htm
  • 福州新闻网 — 福建印发”十五五”教育发展规划 到2030年普高招生计划比例力争达八成: https://news.fznews.com.cn/dsxw/20260830/6a9384b95dc47.shtml

相关阅读

  • 见：外国大学如何进入中国——中外合作办学路径（sino-foreign-cooperative-education-pathways）
  • 见：海南国际教育创新岛试验（356-hainan-international-education）
Healthcare & Pharma / 医药医疗

China’s drug traceability rules harden: full coding, full scanning from NMPA Announcement No. 85 of 2026

  • On 1 September 2026, the National Medical Products Administration (NMPA) published Announcement No. 85 of 2026 on Further Strengthening the Administration of Drug Information Traceability (dated 31 August 2026), demanding full-variety coding (“应赋尽赋”) and full-chain scanning (“见码必扫”).
    2026年9月1日，国家药监局发布《关于进一步加强药品信息化追溯管理工作的公告》（2026年第85号，落款2026年8月31日），提出”全品种赋码、应赋尽赋，全链条扫码、见码必扫”的总要求。
  • The announcement hardens legal duties across the whole chain — marketing-authorisation holders (MAHs), domestic agents of overseas MAHs, manufacturers, distributors, medical institutions and traceability-system operators — and, with limited exceptions (active pharmaceutical ingredients, medical oxygen, hospital preparations), all finished dosage forms in production must be coded; TCM decoction pieces follow separate rules.
    公告压实持有人、境外持有人指定境内责任人、生产企业、经营企业、使用单位及追溯系统运营单位等各方责任；除原料药、医用氧、医疗机构制剂等少数品类外，全部在产制剂品种均须赋码（中药饮片追溯要求另行制定）。
  • Code registration is tightened: MAHs and domestic agents must file drug identifier codes on the national co-ordination platform through the NMPA government-service portal and link identifier code, commodity bar code, national drug code and medical-insurance code; issuing bodies and system operators must also file to guarantee uniqueness.
    追溯码备案趋严：持有人、境内责任人须通过国家药监局政务服务门户登录国家药品追溯协同服务平台，及时准确完整备案药品标识码，完成标识码、商品条码、本位码、医保编码等多码关联；发码机构与系统运营单位须向平台备案以确保唯一性。
  • Distributors and end-users face hard scanning rules: wholesalers must treat code verification as a mandatory part of inbound acceptance and upload information on outbound review; pharmacies and medical institutions must verify codes on inbound acceptance, upload sales records, and refuse goods whose traceability shows they were already sold at another retail outlet; abnormal alerts require stopping sales pending quality-manager review.
    经营使用环节扫码成为硬性流程：批发企业须把扫码核对作为入库验收的必须内容并在出库复核时上传信息；零售药店与医疗机构入库验收须核对追溯码、销售时上传销售信息；发现追溯信息显示药品已在其他零售或使用单位售出的应拒收；出现异常预警应立即停止入库和销售，由质量负责人审核签字后处理。
  • For pharmaceutical companies importing into China and their local partners, the message is that traceability has moved from infrastructure-building to routine enforcement: performance will be woven into daily inspections by provincial drug administrations, with tampering or fabrication of traceability data punished under the Drug Administration Law and GSP-related rules.
    对进口药品企业与本地合作伙伴而言，信号明确：药品追溯已从”建基础设施”进入”常态化监管执法”阶段——省级药监部门将把追溯落实情况纳入日常检查，篡改、伪造追溯数据或不落实追溯义务者将依《药品管理法》《药品经营和使用质量监督管理办法》等严肃处理。

China’s drug traceability rules harden: full coding, full scanning from NMPA Announcement No. 85 of 2026 | 药品追溯进入”全品种全链条”强监管：国家药监局2026年第85号公告解读

Overview

On 1 September 2026, the National Medical Products Administration (NMPA) published Announcement No. 85 of 2026 on Further Strengthening the Administration of Drug Information Traceability (《国家药监局关于进一步加强药品信息化追溯管理工作的公告（2026年第85号）》), dated 31 August 2026. Building on the Drug Administration Law and its implementing regulations, the announcement consolidates years of pilot infrastructure into a compulsory, enforceable regime: every product coded, every code scanned, and every link answerable. NMPA officials described the drug traceability code as each pack’s “electronic identity card”, capable of recording where a product has been approved and how it moved through production and distribution.

The core principle: 应赋尽赋, 见码必扫

The announcement states the overall requirement as “full-variety coding — everything that should be coded must be coded; full-chain scanning — every code that appears must be scanned”. The coverage is nearly universal: with the exceptions of active pharmaceutical ingredients, medical oxygen and hospital preparations, all finished dosage forms in production fall within the traceability scope. Traditional Chinese medicine decoction pieces are governed by separate rules to be issued. This means imported finished drugs distributed in China are squarely within the regime, and their MAHs and domestic agents carry the first-layer obligations.

Duties by link in the chain

MAHs and domestic agents of overseas MAHs (持有人、境内责任人). They must:

  • file drug identifier codes through the NMPA government-service portal on the national drug traceability co-ordination platform, accurately and completely, linking the identifier code, commodity bar code, national drug code (本位码) and medical-insurance code;
  • follow the “one object one code, code and object tracked together” (一物一码、物码同追) principle, completing traceability-code activation before market launch, linking codes across all levels of sales packaging, and uploading traceability information accurately and promptly;
  • save in-warehouse records in the traceability system at finished-goods receipt, provide downstream traceability information at outbound sale, and promptly handle abnormal-code feedback from downstream parties so that information remains truthful and credible.

Manufacturers (生产企业). Alongside MAHs, they are responsible for coding activation and packaging-linkage before products are placed on sale, and for accurate, timely uploads.

Wholesale distributors (批发企业). Inbound acceptance must include obtaining traceability information from the upstream party and verifying the traceability code as a mandatory part of acceptance; they must feed receipt information back upstream and, at outbound-sale review, provide traceability information to downstream enterprises or medical institutions through the system.

Retail pharmacies and medical institutions (零售药店、医疗机构). On inbound acceptance they must verify codes against the upstream party and feed receipt information back; when selling, they must keep detailed sales records and upload sales information through the traceability system in a timely manner. Sales receipts must display the traceability code or offer another convenient query channel for consumers. Where the system raises an abnormal alert, the pharmacy or institution must immediately stop inbound acceptance and sales, verify and handle the alert, with the measures signed off by the quality manager and records kept per GSP requirements. Where inbound acceptance reveals traceability information showing the drug was already sold at a retail pharmacy or medical institution, the goods must be refused.

Traceability-system operators (追溯系统运营单位). They must maintain public-interest orientation, guarantee data security, provide recall support for MAHs and domestic agents, offer real-time early warning of abnormal traceability signals at inbound acceptance for wholesale, retail and user units, protect personal privacy and trade secrets in traceability data, and not disclose or illegally provide data to others. They must file with the national platform to ensure code uniqueness.

Supervision and enforcement

The announcement asks provincial drug administrations to make traceability performance part of daily inspection of enterprises and units in their regions, pushing full-variety coding activation and full-chain scanning and uploading (“应赋尽赋、应扫尽扫”). Entities that fail to comply with the regulations or with traceability requirements are to be handled seriously under the Drug Administration Law, the Measures for the Supervision and Administration of Drug Operation and Use, and the Good Supply Practice (GSP) rules. NMPA also stresses “三医协同” — co-ordination among the drug, medical-insurance and health authorities — and the use of traceability data for smart supervision, risk discovery and rapid handling. The data-security angle is explicit: system operators must build data-security management institutions under the Data Security Law and keep private and commercial data confidential.

Why this matters to foreign pharmaceutical companies

  • Traceability compliance is now an enforcement matter, not a project. Foreign MAHs importing finished drugs must ensure their domestic agent (境内责任人) operates the full coding-and-uploading cycle on the national platform. The agent is a regulated extension of the MAH; a weak agent means personal exposure for the MAH’s China compliance posture.
  • Multi-code linkage affects packaging and IT work. Linking the identifier code, commodity bar code, national drug code and medical-insurance code means packaging data and enterprise resource systems must be reconciled with Chinese regulatory identifiers before first import. Imported products already carrying GS1 codes still need the Chinese identifier-code linkage.
  • Channel discipline improves for compliant players. The rule that goods already sold elsewhere must be refused, and that abnormal alerts stop sales, directly attacks “reflux drugs” (回流药) and code-swapping fraud — problems that undercut legitimate pricing. Compliant importers benefit as grey channels close.
  • GSP-grade documentation is required across the distributor network. Distributors’ inbound/outbound scanning and the quality-manager sign-off on abnormal alerts become audit evidence; foreign firms should verify their Chinese distributors’ systems actually generate this documentation.
  • Co-ordination with medical-insurance settlement. NMPA links traceability to medical-insurance code-based settlement; announcements and practice increasingly tie code verification to reimbursement and anti-fraud work, so products without sound traceability data may face friction in hospital and insurance-channel reimbursement.

Practical steps

  • Confirm that the domestic agent of each imported MAH has an up-to-date registration on the national traceability co-ordination platform with correct multi-code linkage for every marketed SKU.
  • Audit packaging and labelling projects to ensure traceability codes, bar codes and hierarchy linkage are complete before first shipment into China.
  • Review distributor contracts to require GSP-compliant inbound/outbound scanning, abnormal-alert handling and quality-manager sign-off records.
  • Align internal ERP/quality systems with the platform’s data-upload requirements, including timely handling of downstream abnormal-code feedback.
  • Monitor provincial enforcement and any TCM-decoction-piece traceability rules still to be issued, and track the interaction between traceability and medical-insurance settlement in tender and hospital channels.

Sources

  • 国家药监局 — 国家药监局关于进一步加强药品信息化追溯管理工作的公告（2026年第85号）: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260901134430105.html
  • 医药网 — 药品追溯新规出台 压实全产业链主体监管责任: https://news.pharmnet.com.cn/news/2026/09/02/625299.html
  • 央视新闻（辽宁药监转载）— 视频丨国家药监局：药品追溯须覆盖全品种全链条: https://www.toutiao.com/article/7681111672232100387

Related reading

  • see also: China’s drug import licensing and GSP obligations for foreign MAHs (drug-import-licensing-gsp)
  • see also: medical-device UDI roll-out and the parallel “drug-device same-traceability” agenda (medical-device-udi)

药品追溯进入”全品种全链条”强监管：国家药监局2026年第85号公告解读

概述

2026年9月1日，国家药监局发布《关于进一步加强药品信息化追溯管理工作的公告》（2026年第85号，落款2026年8月31日）。公告依据《药品管理法》及其实施条例制定，把多年试点形成的基础设施升级为强制性、可执行的全链条制度：每个产品赋码、每个码必扫、每个环节可追责。药监局官员将药品追溯码形容为每一盒药的”电子身份证”，扫码即可记录和获取药品获批及生产流通环节的详细信息。

总原则：应赋尽赋、见码必扫

公告确立的总要求是”全品种赋码、应赋尽赋；全链条扫码、见码必扫”。覆盖面近乎全面：除原料药、医用氧、医疗机构制剂等少数品类外，全部在产制剂品种纳入追溯范围；中药饮片追溯要求另行制定。这意味着在华流通的进口制剂同样完全落入该制度，其持有人与境内责任人承担第一层义务。

各环节义务

持有人、境外持有人境内责任人。 须：通过国家药监局政务服务门户登录国家药品追溯协同服务平台，及时、准确、完整备案药品标识码，完成标识码、商品条码、本位码、医保编码等多码关联；按照”一物一码、物码同追”原则，在上市销售前完成追溯码赋码激活、各级销售包装单元追溯码关联并及时准确上传追溯信息；成品入库时在追溯系统保存入库信息，销售出库时向下游企业或使用单位提供追溯信息；及时处理下游反馈的追溯码异常信息，保障信息真实可信。

生产企业。 与持有人共同落实赋码激活与包装层级关联，及时准确上传信息。

批发企业。 入库验收时必须通过追溯系统向上游索取追溯信息、进行追溯码核对，将扫码核对作为入库验收的必须内容并反馈收货信息；出库复核时向下游企业或医疗机构提供追溯信息。

零售药店与医疗机构。 入库验收时与上游核对追溯码并反馈收货信息；销售时保存销售记录明细并及时上传销售信息；销售小票应显示追溯码或提供便捷查询渠道。追溯系统出现异常预警的，应立即停止入库和销售，核实处理并由质量负责人审核签字后实施，按GSP要求保存记录。入库验收发现追溯信息显示该药品已在其他零售或使用单位售出的，应当拒收。

追溯系统运营单位。 坚持公益性导向，保障数据安全；为持有人、境内责任人提供召回支持；为批发、零售、使用单位提供入库环节异常信号实时预警；对追溯信息中可能含有的个人隐私、商业秘密依法保密，不得泄露或非法提供；向国家平台备案确保追溯码唯一性。

监管与执法

公告要求各省级药监部门把追溯落实情况纳入对企业和单位的日常检查，督促做好全品种赋码激活与全链条扫码上传，做到”应赋尽赋、应扫尽扫”。对不落实法规规定、不符合追溯工作要求的，依照《药品管理法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等严肃处理。公告强调”三医协同”（药监、医保、卫健），依托大数据智慧监管，提升风险发现与处置能力。数据安全要求明确：系统运营单位须依《数据安全法》建立数据安全管理制度。

对外资药企的意义

  • 追溯合规进入执法阶段，不再是”项目”。 进口制剂的外国持有人必须确保其境内责任人在国家平台完整运行赋码与上传闭环。境内责任人是持有人监管职能的延伸；责任人履职不力将直接拖累持有人整体在华合规态势。
  • 多码关联影响包装与IT工作。 标识码、商品条码、本位码、医保编码的关联意味着包装数据与ERP系统须在首次进口前与中国监管标识体系对齐。已带GS1条码的进口产品仍需完成中文标识码关联。
  • 合规玩家的渠道秩序改善。 “已在别处售出即拒收”与”异常预警即停售”直击回流药与串换编码乱象——这些乱象侵蚀合法定价体系。灰色渠道收窄，合规进口商受益。
  • 分销网络需具备GSP级文档能力。 分销商出入库扫码与质量负责人对异常预警的签字成为审计证据；外企应核实中国分销商系统确实能生成此类记录。
  • 与医保结算联动。 追溯与依码结算政策协同，扫码核验日益与报销、基金稽查挂钩；追溯数据不健全的产品在医院与医保渠道的报销可能受阻。

实务建议

  • 确认每个进口上市许可持有人的境内责任人在国家追溯协同平台登记有效，且每个在售SKU多码关联正确。
  • 审计包装与标签项目，确保追溯码、条码与层级关联在首次进入中国市场前完备。
  • 修订经销商合同，要求GSP合规的出入库扫码、异常预警处理与质量负责人签字记录。
  • 将内部ERP/质量系统与国家平台数据上传要求对齐，包括及时处理下游异常码反馈。
  • 跟踪省级执法动态与待出台的中药饮片追溯规则，并关注集采挂网与医院渠道中追溯与医保结算的衔接。

来源

  • 国家药监局 — 国家药监局关于进一步加强药品信息化追溯管理工作的公告（2026年第85号）: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260901134430105.html
  • 医药网 — 药品追溯新规出台 压实全产业链主体监管责任: https://news.pharmnet.com.cn/news/2026/09/02/625299.html
  • 央视新闻（辽宁药监转载）— 视频丨国家药监局：药品追溯须覆盖全品种全链条: https://www.toutiao.com/article/7681111672232100387

相关阅读

  • 见：外国持证人的药品进口许可与GSP义务（drug-import-licensing-gsp）
  • 见：医疗器械UDI分批强制与”药械同追”议程（medical-device-udi）
Visa-Free Transit / 过境免签

Yiwu Airport opens port-visa services: “free transit + port visa” now covers China’s world supermarket

  • On 16 July 2026, Yiwu Airport in Jinhua, Zhejiang issued its first batch of port visas — the first port-visa service at a county-level air port in the province and a milestone in deepening the “free-transit-plus-port-visa” entry convenience system for foreign business travellers.
    2026年7月16日，浙江金华义乌机场签发首批口岸签证——这是浙江省县级航空口岸首次落地口岸签证业务，标志着义乌”过境免签+口岸签证”双轨并行的外籍客商入境便利体系成形。
  • Port visas serve foreigners with urgent entry needs who hold ordinary passports but could not obtain a visa abroad in time — for business, investment, exhibitions, tourism, family visits or private emergencies — and can be applied for and issued on arrival at the port (“落地即办、即办即取”).
    口岸签证面向持普通护照、因紧急商务等事由来不及在境外办妥签证的外籍人员，可在抵达口岸后即时受理、即时审批、即时签发，实现”落地即办、即办即取”。
  • Yiwu’s numbers explain the demand: in 2025 the city received over 680,000 foreign-visitor arrivals, hosted about 38,000 resident foreigners, and counted more than 10,000 foreign-invested business entities — the highest of any county-level city; import-export volume exceeded RMB 830 billion.
    义乌的数据解释了需求：2025年义乌接待外籍客商超68万人次、常住外籍人士约3.8万人、外资经营主体超1万户（居全国县级市首位），进出口总额超8300亿元人民币。
  • The port visa complements the 240-hour visa-free transit already in place at Yiwu Airport since the end of 2024: transit solves “passing through” convenience, the port visa solves “coming specially for” urgency — together they cut the cost of last-minute business trips for foreign buyers and suppliers.
    口岸签证与此前实施的240小时过境免签互补：过境免签解决”路过”的便捷，口岸签证解决”专程来”的急迫，共同降低外籍采购商与供货商临时商务来华的成本。
  • For foreign companies and trade intermediaries, the practical effect is a shorter, cheaper route for overseas customers to reach China’s largest small-commodity market on short notice — reducing order losses caused by visa delays and reinforcing Yiwu’s position as a global sourcing hub.
    对外国企业与贸易中介而言，实际效果是海外客户临时来华抵达全球最大小商品市场的路径更短更省——减少因签证延误导致的订单流失，巩固义乌作为全球采购中心的地位。

Yiwu Airport opens port-visa services: “free transit + port visa” now covers China’s world supermarket | 义乌机场落地口岸签证：”免签+签证”双通道打通外商来华”最后一公里”

Overview

On 16 July 2026, two foreign buyers — Egyptian purchaser Ayman and Niger businessman Mohammed — landed at Yiwu Airport in Jinhua, Zhejiang, completed visa formalities at the airport’s port-visa counter and entered China. These were the first port visas issued at Yiwu and the first time a county-level air port in Zhejiang provided port-visa services. The development was reported nationally in September 2026 as a defining step in Yiwu’s international-personnel convenience reform, pairing the 240-hour visa-free transit already available at the airport since end-2024 with an on-arrival visa channel for urgent visits.

What a port visa is

Under China’s visa regime, a port visa (口岸签证) is a visa issued by the public-security exit-entry administration at designated ports to foreigners who, holding valid international travel documents, need to enter China urgently for reasons including business co-operation, investment and entrepreneurship, exhibitions, tourism, family visits and private emergencies, and who did not have time to obtain a visa from a Chinese embassy or consulate abroad. Eligibility requires ordinary-passport holders with material supporting the urgent purpose. The visa can be applied for at the port counter on arrival, with immediate acceptance, review and issuance — in the Yiwu case, the first two buyers completed the process and cleared immigration in about half an hour.

The service is designed for genuine urgency rather than routine travel: it removes the need to fly to another Chinese city with a visa office, apply there, and then travel onwards to Yiwu.

Why Yiwu: the numbers behind the reform

Yiwu is a city “built on a market” — more than 2.1 million types of goods flow from it to over 230 countries and regions. In 2025:

  • import-export volume exceeded RMB 830 billion;
  • foreign-visitor arrivals exceeded 680,000;
  • resident foreigners numbered about 38,000;
  • foreign-invested business entities surpassed 10,000 — the most of any county-level city in China.

Buyer Ayman’s own story illustrates the pain point: he had purchased about USD 200,000 of goods in Yiwu the previous year; with his order at the closing stage he urgently needed to come for inspection and container loading, and a conventional embassy visa application would have delayed the shipment. The port visa let him land and transact within the day.

How the two channels fit together

Since the end of 2024, China’s national immigration authority extended visa-free transit to 240 hours and added Yiwu International Airport to the list of ports where visa-free transit applies. The two mechanisms now complement each other:

  • 240-hour visa-free transit serves travellers who are “passing through” — short stays for inspection, meetings or connecting itineraries;
  • Port visa serves travellers “coming specially” — buyers who need to inspect goods, close deals, check factories or attend exhibitions at short notice.

Local officials frame the pairing as one “channel” (免签疏、签证引): together they clear the bottleneck that previously forced foreign buyers to route through other ports with visa offices, adding time, money and lost orders.

Behind the scenes: how Yiwu prepared

The port-visa service did not appear overnight. Jinhua formed a dedicated working group and engaged the National Immigration Administration and provincial authorities to obtain the approval — an item under Yiwu’s new round of 38 power-expansion reforms. Yiwu’s public-security exit-entry administration completed the construction of the port-visa area and a professional service team, and the airport now runs a full-chain inbound service package: a first-stop consultation point for arriving passengers, a payment-facilitation service area for inbound foreigners, and a duty-free/export-tax-refund service point. During the summer peak, the airport operated “one route one policy, one flight one plan” with the immigration inspection station, bilingual guides for groups and families, a dedicated processing zone for visa-free passengers, and a multilingual electronic arrival-declaration system.

Since the reform, Yiwu has added one new international direct route, doubled the number of international transit cities year on year, and recorded a 16.5 per cent year-on-year increase in registered temporary inbound foreigners; professional exhibition halls now host on average one show a week, and the frequency of international sourcing and supply-demand matching events has doubled.

What this means for foreign companies and intermediaries

  • Lower cost of last-minute trips. For buyers sourcing in Yiwu, the ability to arrive and obtain a visa on the spot protects urgent orders that previously risked being lost to visa timelines. Companies hosting buyer delegations should factor the port-visa channel into invitation and logistics planning.
  • A full “airport-to-market” corridor. With the port visa added to visa-free transit, the practical journey for a buyer is now: fly to Yiwu Airport, clear immigration, and walk into the market — the province promotes it as “exit the airport, enter the market”, and the same corridor connects to Jinhua’s wider industrial belts and tourism resources such as Hengdian World Studios.
  • Structured business facilitation. Yiwu’s “one matter” digital reforms let merchants pre-submit buyer materials to the exit-entry authorities, so verification on arrival is faster (“pre-submission of declarations, issue on landing”); foreign companies using Chinese intermediaries should ask whether their Yiwu partners can pre-file buyer data.
  • Longer-term signals for investors. The pairing of visa-free transit and port visas is part of a broader push by Zhejiang and Yiwu to deepen institutional opening — relevant context for foreign firms considering distribution, sourcing offices or market-entry projects in the region.

Practical steps

  • For foreign buyers planning urgent Yiwu trips: check whether the purpose qualifies for a port visa and prepare the supporting documents (invitation letter, purchase orders, exhibition registration) before boarding.
  • Verify whether your Chinese partner or the Yiwu exit-entry administration can pre-submit buyer materials to shorten on-arrival processing.
  • If your visitors are merely transiting for a short stay, compare the 240-hour visa-free transit route and the port-visa route to decide which applies.
  • Use the airport’s inbound service points (consultation, payment facilitation, tax refund) when arranging staff or customer arrivals.
  • Monitor further immigration-facilitation pilots in Jinhua and Zhejiang as the “free transit + port visa” model is extended.

Sources

  • 义乌市人民政府门户网站 — 当越来越多外国人飞来义乌（口岸签证与240小时过境免签互补）: https://www.yw.gov.cn/col/col1229425018/art/2026/art_231db578fda5460b850fa2482b51cd59.html
  • 中国新闻网（今日头条转载）— “世界超市”浙江义乌启用口岸签证 外籍人士入境再提速: https://www.toutiao.com/article/7663128579190374918
  • 金台资讯（今日头条转载）— 金华”免签+签证”并行畅通外商入境路: https://www.toutiao.com/article/7681477399858479654/

Related reading

  • see also: China’s 240-hour visa-free transit expansion and how to use it (303-visa-free-transit-expansion)
  • see also: first-week operations data of the expanded transit policy (346-transit-visa-expansion-first-week)

义乌机场落地口岸签证：”免签+签证”双通道打通外商来华”最后一公里”

概述

2026年7月16日，埃及采购商艾曼与尼日尔客商穆罕默德抵达浙江金华义乌机场，在机场口岸签证窗口完成签证办理并通关入境。这是义乌签发的首批口岸签证，也是浙江县级航空口岸首次落地口岸签证业务。2026年9月，这一进展被作为义乌国际人员往来便利化改革的关键一步在全国报道——它与此前已实施的240小时过境免签政策组合，形成”过境免签+口岸签证”双轨并行的外籍客商入境体系。

什么是口岸签证

依据中国签证制度，口岸签证（port visa）是由公安机关出入境管理部门在指定口岸向外籍人员签发的签证，适用对象为：持有效国际旅行证件，因商贸合作、投资创业、展会访问、观光旅游、探亲及私人紧急事务等非公务类事由急需入境，且来不及在境外中国使领馆办妥签证的外国人。口岸签证可在抵达口岸后于口岸窗口申请，即时受理、即时审批、即时签发——义乌首批两名客商在半小时左右即完成办证与通关。

该服务针对的是真实紧急需求而非常规旅行：它免去了先飞到其他设有签证机构的口岸城市办证、再辗转赴义的奔波。

为什么是义乌：改革背后的数字

义乌是一座”建在市场上的城市”——超210万种商品从这里发往全球230多个国家和地区。2025年：

  • 进出口总额超8300亿元人民币；
  • 入境外籍客商超68万人次；
  • 常住外籍人士约3.8万人；
  • 外资经营主体超1万户，居全国县级市首位。

采购商艾曼的经历直观呈现痛点：他上一年在义乌采购约20万美元商品，眼下订单进入尾声、急需来义验货装柜；走常规使领馆签证将延误货期。口岸签证让他当日落地、当日进入交易流程。

两条通道如何互补

2024年底起，国家移民管理局将过境免签停留时间统一延长至240小时，并把义乌国际机场列入新增过境免签口岸名单。如今两套机制互补：

  • 240小时过境免签服务”路过”型旅客——短期停留看样、洽谈或中转过境；
  • 口岸签证服务”专程来”型旅客——需要临时验货、谈单、看厂、参展的采购商。

当地官方把组合概括为一”疏”一”引”：两条通道共同打通外籍客商来义堵点。此前外国客商有紧急入境需求，往往要先到其他口岸办证再中转来义；如今在义乌机场即可直接办理。

背后的准备

口岸签证并非一蹴而就。金华组建攻坚专班，对接国家移民管理局及省级主管部门争取口岸签证扩权——这是义乌新一轮38项扩权赋能改革的核心举措之一。义乌市公安局出入境管理部门完成了口岸签证办证区域建设并组建专业服务队伍，机场同步打造全链条入境服务：入境旅客首站咨询点、境外来华人员支付便利化服务区、离境退税服务点。暑运期间，机场联动出入境边检站落实”一航线一政策、一航班一方案”，为外籍团体与家庭旅客增配双语引导人员，单设免签旅客专属办理区，全面上线多语种入境电子申报系统。

改革落地后，义乌机场新增国际直飞航线1条，国际中转通航城市数量同比翻番，全市登记临时入境境外人员同比增长16.5%；专业展馆平均”一周一展”，国际采购与供需对接活动频次翻倍。

对外国企业与贸易中介的意义

  • 临时来华成本下降。 对在义采购的买家而言，落地即可办证保护了此前可能因签证周期流失的紧急订单。接待采购团的企业应把口岸签证通道纳入邀请与行程规划。
  • “机场到市场”全走廊成形。 口岸签证叠加免签过境后，买家的实际动线是：直飞义乌机场、通关、进场采购——当地称之为”出了机场就进市场”，同一走廊还连接金华全域产业带及横店影视城等文旅资源。
  • 商务便利结构化。 义乌推行”通关一件事”数字化改革，商户可提前向出入境部门提交外商材料初核，客商抵达核验后当场签发，实现”申报前置、落地即办”；通过中国中间商采购的外企，应询问义乌伙伴能否预提交买家材料。
  • 对投资者的长期信号。 免签+口岸签证的组合是浙江与义乌深化制度型开放的一部分——对考虑在该区域设立分销、采购办事处或市场进入项目的外企而言，这是重要背景。

实务建议

  • 计划紧急赴义乌的外国买家：出行前确认事由是否符合口岸签证条件，备妥邀请函、采购订单、展会登记等支持材料。
  • 核实中国合作方或义乌出入境部门能否预提交买家材料以缩短落地办理时间。
  • 若来访人员只是短期过境，比较240小时过境免签与口岸签证两条路径后选择适用者。
  • 安排员工或客户抵达时使用机场入境服务点（咨询、支付便利、退税）。
  • 跟踪金华与浙江”免签+签证”模式的延伸，关注后续出入境便利化试点。

来源

  • 义乌市人民政府门户网站 — 当越来越多外国人飞来义乌（口岸签证与240小时过境免签互补）: https://www.yw.gov.cn/col/col1229425018/art/2026/art_231db578fda5460b850fa2482b51cd59.html
  • 中国新闻网（今日头条转载）— “世界超市”浙江义乌启用口岸签证 外籍人士入境再提速: https://www.toutiao.com/article/7663128579190374918
  • 金台资讯（今日头条转载）— 金华”免签+签证”并行畅通外商入境路: https://www.toutiao.com/article/7681477399858479654/

相关阅读

  • 见：中国240小时过境免签扩容与使用要点（303-visa-free-transit-expansion）
  • 见：过境免签扩容首周运行数据（346-transit-visa-expansion-first-week）
Patent / 专利

China’s patent fast-track gets a 2026 reset: new Prioritised Examination Measures effective 1 September

  • The China National Intellectual Property Administration (CNIPA) published the revised Measures for the Prioritised Examination of Patents (Order No. 85), adopted at its 4th bureau meeting on 16 July 2026 and effective from 1 September 2026, repealing the 2017 version (Order No. 76).
    国家知识产权局公布新修订《专利优先审查管理办法》（局令第85号）：2026年7月16日经第4次局务会议审议通过、7月28日公布，自2026年9月1日起施行，2017年版（局令第76号）同时废止。
  • The scope of prioritised examination now covers invention applications in substantive examination that have not yet received a first office action, utility-model and design applications, and re-examination and invalidation cases — while fast-track channels via bilateral/multilateral agreements or IP protection centres are expressly excluded.
    优先审查适用范围涵盖处于实质审查阶段且未作出首次处理的发明专利申请、实用新型和外观设计专利申请，以及复审案件和无效宣告案件；依据双边或多边协议开展优先审查、或经知识产权保护中心预审合格快速审查的，按有关规定处理，不适用本办法。
  • Eligibility for priority centres on innovation value and transformation prospects: emerging and future industries or key-core-technology breakthroughs, industries encouraged by provincial or municipal governments, applicants already industrialising or ready to industrialise (or evidence that others are implementing the invention), first-filing-in-China applications later filed abroad with substantive-examination requests, and other cases of major national or public interest.
    优先审查的适格条件聚焦创新价值与转化前景：涉及新兴产业和未来产业或关键核心技术攻关；涉及省级或设区的市级人民政府重点鼓励的产业；申请人已产业化实施或已做好实施准备、或有证据证明他人正在实施；就相同主题首次在中国申请后又向其他国家或地区提出实质审查请求的；对国家利益或公共利益具有重大意义的其他情形。
  • Reform highlights include tighter management with central-local co-ordination, quality-oriented handling that disciplines violation of good-faith principles, and procedure-level convenience: electronic XML filing, no extra fees for prioritised examination, and clarified processing rules.
    本次修改突出：强化央地协同、规范省级推荐管理；质量导向，对违反诚信原则行为设罚则；程序便利化——采用XML格式电子申请、优先审查不收取额外费用、优化办理手续。
  • For foreign applicants, the key practical point is territorial eligibility: for applications and re-examination requests, the first applicant’s address must be within China (provincial IP offices recommend); overseas and Taiwan-China-region applicants requesting prioritised examination must show the application positively promotes the province’s industrial upgrading and technical iteration, and file in paper form where required.
    对外国申请人最关键的实际要点是地域适格：专利申请与复审案件请求优先审查，第一申请人地址须在中国境内（由省级知识产权局推荐）；境外及中国台湾地区申请人提出请求的，其专利申请应对本省产业升级、技术迭代有积极促进作用，且按规定以纸件方式提出。

China’s patent fast-track gets a 2026 reset: new Prioritised Examination Measures effective 1 September | 专利”快车道”2026版重启：新《专利优先审查管理办法》9月1日施行

Overview

On 28 July 2026, the China National Intellectual Property Administration (CNIPA) published the revised Measures for the Prioritised Examination of Patents (《专利优先审查管理办法》) as Order No. 85, adopted at the 4th CNIPA bureau meeting on 16 July 2026. The Measures took effect on 1 September 2026, replacing the 2017 version (Order No. 76). Prioritised examination is China’s formal fast-track within the ordinary examination system — distinct from the PPH-style channels under bilateral/multilateral agreements and from pre-examination-based fast channels at intellectual-property protection centres — and the revision rebalances eligibility, tightens management and modernises procedure. For foreign patent applicants with Chinese filings, the changes affect who can ask for the fast track, how the request is made, and what supporting evidence is expected.

What the revised scope covers

Under the new Measures, prioritised examination applies to:

  • invention applications that are in substantive examination and have not yet received a first office action (首次处理, i.e. the examiner has begun examination and issued a notification);
  • utility-model and design applications;
  • re-examination cases for invention, utility-model and design patents; and
  • invalidation cases for invention, utility-model and design patents.

Expressly outside the Measures are prioritised examination conducted under bilateral or multilateral agreements between CNIPA and foreign offices, and fast-track examination of applications that have passed pre-examination at a national IP-protection centre or rapid-rights-protection centre — those follow their own rules.

The five eligibility grounds

An applicant or re-examination requester may request prioritised examination where the application or case has significant innovation value and transformation prospects and falls under one of five categories:

  1. Emerging and future industries, or key-core-technology breakthroughs (新兴产业和未来产业，或者关键核心技术攻关);
  2. industries encouraged by a provincial or city-level government (省级或设区的市级人民政府重点鼓励的产业);
  3. the applicant has already industrialised or prepared to industrialise, or there is evidence that others are implementing the invention;
  4. the application was first filed in China and a substantive-examination request is later made in another country or region for the same subject matter (a Chinese priority-anchor case); and
  5. other circumstances of major significance to national or public interests.

For invalidation cases, either the invalidation requester or the patentee may request prioritised examination in listed circumstances, including where the patent is involved in infringement disputes and a local IP administration or court is handling the matter.

What changed: three reform themes

1. Adjusted eligibility to serve national priorities. The revision sharpens the focus on high-quality applications in emerging and future industries, adapts the scope to the amended Patent Law and its implementing rules, clarifies circumstances in which prioritised examination will not be granted, and anchors the regime to supporting new-quality productive forces and an innovation-friendly business environment.

2. Full-lifecycle management with a quality orientation. Institutionally, the Measures strengthen central-local co-ordination: CNIPA manages prioritised examination nationwide, receives requests recommended by relevant State Council departments, and reinforces review-resource guarantees; provincial IP offices handle recommendation of requests in their regions and are guided to strengthen management of requesting entities and provide targeted services. In examination organisation, acceptance, review and examination stages are more tightly regulated to raise quality and efficiency. At the source, the Measures emphasise the technical-innovation and transformation value of prioritised cases, strengthen the service guarantee provided by patent agencies to requesting entities, and — notably — impose sanctions for conduct violating the principle of good faith, holding the quality bottom line.

3. Procedure-level convenience. Document requirements are streamlined to make it easier to submit requests; prioritised examination is confirmed to incur no additional fee; and processing rules address issues that practice had flagged, absorbing mature and effective existing approaches.

The filing mechanics

Requests are made electronically in XML format through the patent business-processing system (the relevant module of the system was upgraded online from 1 September 2026). For invention applications, the request must be accompanied by a statement of reasons and supporting documentation including, where applicable, the latest search report of the State Intellectual Property Office or a search report from a foreign office or international organisation, plus evidence of the status of the relevant technical field. Because prioritised examination compresses the examination timeline, the accompanying search report and prior-art material materially determine whether the case can proceed quickly once admitted.

Provincial IP offices make the recommendation for applications and re-examination cases whose first applicant is located in their province; CNIPA receives requests recommended by relevant State Council departments directly. All applicants, re-examination requesters or patentees must consent to the request. For invalidation cases, local IP administrations, courts and arbitration institutions may directly request prioritised examination from CNIPA for patents involved in their cases without provincial recommendation.

What this means for foreign applicants

  • Territorial eligibility is the gate. For patent applications and re-examination cases, prioritised examination requires the first applicant’s address to be in China — the practical route for foreign companies is filing through their Chinese subsidiary, joint venture or licensee as first applicant. Overseas applicants without a Chinese address generally cannot use this fast track for ordinary applications; they instead rely on PPH-type channels or protection-centre pre-examination where applicable.
  • A defined route for overseas and Taiwan-China-region applicants. The Fujian provincial IP authority’s guidance issued with the September 2026 implementation confirms that where overseas and Taiwan-China-region applicants do request prioritised examination, their applications must positively promote the province’s industrial upgrading and technical iteration and effectively lift regional technical capability, and the request must be submitted in paper form. This “contribution to local industry” test is the substantive threshold such applicants should prepare evidence for.
  • First-filing-in-China strategy now links to speed. Category 4 explicitly rewards applicants who first file in China and then seek substantive examination abroad on the same subject matter — a structural incentive relevant to multinationals’ global filing strategies and to their China R&D centres.
  • Good-faith discipline raises documentation standards. The new sanctions for violating good-faith principles mean requests must be supported by genuine evidence (industrialisation, infringement, or other use); speculative or mass requests designed only to jump the queue now carry reputational and procedural risk.
  • Provincial recommendation is a real step. Because provincial IP offices recommend requests, engagement with the province where the Chinese entity is registered matters; provinces with strong innovation-support policies can be expected to prioritise high-value filings aligned with their encouraged industries.

Practical steps

  • Map your China filings to the five eligibility grounds and identify which province will recommend each request.
  • For overseas entities without a Chinese first applicant, confirm the fallback route (PPH, protection-centre pre-examination) and, where provincial prioritised examination is sought, prepare the industrial-upgrade and capability-lift evidence and expect paper filing.
  • Verify that the application has not yet received a first office action before requesting prioritised examination; an application already under active examination is ineligible under the revised definition.
  • Prepare the search-report material: a CNIPA or foreign/international search report strengthens the request.
  • File electronically in XML via the patent business-processing system and watch provincial IP-office implementation guidance issued through late 2026.

Sources

  • 国家知识产权局 — 专利优先审查管理办法（局令第85号，全文）: https://www.cnipa.gov.cn/art/2026/7/30/art_74_207457.html
  • 福建省市场监督管理局（福建省知识产权局）— 关于新修订《专利优先审查管理办法》施行有关事项的提示: https://scjgj.fj.gov.cn/zw/tzgg/202609/t20260904_7209087.htm
  • 央视新闻 — 国家知识产权局发布《专利优先审查管理办法》9月1日起施行: https://so.html5.qq.com/page/real/search_news?docid=70000021_2936a6b219783152

Related reading

  • see also: how patents are examined and enforced in China for foreign filers (patent-prosecution-enforcement-china)
  • see also: China’s IP protection centres and fast-track pre-examination routes (ip-protection-centre-fast-track)

专利”快车道”2026版重启：新《专利优先审查管理办法》9月1日施行

概述

2026年7月28日，国家知识产权局公布新修订《专利优先审查管理办法》（局令第85号）。该办法已于2026年7月16日经国家知识产权局第4次局务会议审议通过，自2026年9月1日起施行，2017年版《专利优先审查管理办法》（局令第76号）同时废止。优先审查是中国普通审查体系内的正式快车道——与依据双边或多边协议开展的PPH类通道、以及经知识产权保护中心预审的快速审查通道相区别——本次修订重新校准了适格条件、收紧管理并现代化了程序。对持有中国专利申请的外国申请人而言，变化影响谁能申请快车道、如何提出请求以及需要准备哪些佐证。

修订后的适用范围

依据新办法，优先审查适用于：

  • 发明专利申请：处于实质审查阶段且未作出首次处理的（首次处理指审查员已开始审查并发出通知书）；
  • 实用新型和外观设计专利申请；
  • 发明、实用新型和外观设计专利申请的复审案件；
  • 发明、实用新型和外观设计专利的无效宣告案件。

明确不适用本办法的是：依据国家知识产权局与其他国家或地区专利审查机构签订的双边或多边协议开展的优先审查，以及经国家级知识产权保护中心、快速维权中心预审合格后开展的快速审查——这些按其规定处理。

五项适格情形

具有重要创新价值以及转化运用前景的专利申请、复审案件，符合下列情形之一的，专利申请人或复审请求人可以请求优先审查：

  1. 涉及新兴产业和未来产业，或者关键核心技术攻关；
  2. 涉及省级或者设区的市级人民政府重点鼓励的产业；
  3. 专利申请人或复审请求人已经产业化实施或者已经做好产业化实施准备，或者有证据证明他人正在实施其发明创造；
  4. 就相同主题首次在中国提出专利申请后，又向其他国家或地区提出实质审查请求的该中国专利申请（以中国为优先权锚点的案件）；
  5. 对国家利益或者公共利益具有重大意义的其他情形。

无效宣告案件方面，涉案专利发生侵权纠纷、当事人已请求地方知识产权局处理或向人民法院起诉等情形的，无效宣告请求人或专利权人均可请求优先审查。

三大改革主题

一、调整适格条件，突出国家需求。 修订进一步聚焦服务新兴产业和未来产业领域的高质量申请；根据新修改的专利法及其实施细则调整适用范围；明确不予优先审查的情形；把制度锚定在支撑新质生产力发展、优化营商环境上。

二、全流程管理、强化质量导向。 制度上强化央地协同：国家知识产权局负责全国管理、受理并审核请求、接收国务院有关主管部门推荐的请求、加强审查资源保障；省级知识产权局负责本区域内请求的推荐，并被引导加强对请求主体的管理和精准服务。审查组织上，受理、审核、审查各环节更加规范，提高审查质量与效率。源头质量上，突出优先审查案件的技术创新和转化运用价值，强化专利代理机构对请求主体的服务保障，并首次对违反诚信原则行为实施相应罚则，筑牢质量底线。

三、优化程序与标准，提升用户体验。 完善现有技术材料提交要求，便利申请人提交请求；明确优先审查服务不收取额外费用；针对实践中反映集中的问题优化具体操作，充分吸纳成熟有效做法。

申请机制

请求须通过专利业务办理系统以XML格式电子提交（2026年9月1日起系统相关模块升级上线）。发明专利申请请求优先审查的，应附理由说明与支持性文件，包括（如适用）国家知识产权局最新检索报告或外国/国际检索报告，以及相关技术领域状况的证明。由于优先审查压缩审查周期，检索报告与现有技术材料在请求获准后能否快速推进起决定性作用。

申请与复审案件的推荐由第一申请人所在地省级知识产权局作出；国家知识产权局直接接收国务院有关主管部门推荐的请求。所有专利申请人、复审请求人或专利权人须一致同意提出请求。无效宣告案件方面，地方知识产权局、人民法院、仲裁机构可直接就涉案专利向国家知识产权局提出优先审查请求，无需省级推荐。

对外国申请人的意义

  • 地域适格是门槛。 专利与复审案件请求优先审查，要求第一申请人地址在中国境内——外国公司的现实路径是以中国子公司、合资企业或被许可方作为第一申请人提交。没有中国地址的境外申请人通常无法为普通申请使用此快车道，只能视情形依托PPH类通道或保护中心预审。
  • 境外及中国台湾地区申请人有明确通道。 福建省知识产权局随2026年9月实施发布的办理提示确认：境外及中国台湾地区申请人请求优先审查的，其专利申请应对本省产业升级、技术迭代具有积极促进作用、能有效带动辖区技术水平提升，且应当以纸件方式提出请求。”对本地产业有贡献”是此类申请人应备好证据的实质性门槛。
  • “先在中国申请”策略与提速挂钩。 第4类情形明确奖励先在中国首次申请、随后就相同主题在境外寻求实质审查的申请人——这是对跨国企业全球申请策略及其在华研发中心的结构性激励。
  • 诚信罚则提高文件标准。 违反诚信原则的新罚则意味着请求须有真实证据支撑（产业化、侵权或其他实施证据）；仅为了插队而进行的投机性或批量请求将面临程序与声誉风险。
  • 省级推荐是实打实的一步。 由于请求由省级知识产权局推荐，与中国实体注册地省份的沟通至关重要；创新支持政策强的省份可望优先推荐与其鼓励产业一致的高价值申请。

实务建议

  • 把中国申请对照五项适格情形逐一梳理，确定每项请求将由哪个省份推荐。
  • 无中国第一申请人的境外主体：确认备用通道（PPH、保护中心预审）；确需争取省级优先审查的，准备产业升级与能力提升证据并预期纸件提交。
  • 请求前确认申请尚未收到首次审查意见——按修订后的定义，已进入实质审查状态的申请不再适格。
  • 准备检索报告材料：国家知识产权局或外国/国际检索报告可增强请求分量。
  • 通过专利业务办理系统以XML格式电子提交，并跟踪2026年下半年各省知识产权局陆续发布的实施指引。

来源

  • 国家知识产权局 — 专利优先审查管理办法（局令第85号，全文）: https://www.cnipa.gov.cn/art/2026/7/30/art_74_207457.html
  • 福建省市场监督管理局（福建省知识产权局）— 关于新修订《专利优先审查管理办法》施行有关事项的提示: https://scjgj.fj.gov.cn/zw/tzgg/202609/t20260904_7209087.htm
  • 央视新闻 — 国家知识产权局发布《专利优先审查管理办法》9月1日起施行: https://so.html5.qq.com/page/real/search_news?docid=70000021_2936a6b219783152

相关阅读

  • 见：外国申请人的中国专利审查与维权（patent-prosecution-enforcement-china）
  • 见：中国知识产权保护中心与预审快车道（ip-protection-centre-fast-track）
Cybersecurity / 网络安全

China’s public security cyberspace inspection regime gets a major upgrade from 1 October 2026

  • The Ministry of Public Security issued Order No. 176, the Measures for Public Security Organs’ Supervision and Inspection of Cyberspace Security, on 6 August 2026; the rules take effect on 1 October 2026 and repeal the 2018 Internet security inspection rules (Order No. 151).
    2026年8月6日，公安部发布《公安机关网络空间安全监督检查办法》（公安部令第176号），自2026年10月1日起施行，2018年发布的《公安机关互联网安全监督检查规定》（公安部令第151号）同时废止。
  • The new measures shift the scope from “internet security” to “cyberspace security”, defined as the combination of network security, data security and information security, and list eight categories of inspection targets including data processors and personal-information processors.
    新办法把监管口径从”互联网安全”升级为”网络空间安全”（即网络安全、数据安全、信息安全三位一体），并列出八类检查对象，数据处理者、个人信息处理者被明确纳入。
  • Routine on-site inspection of operators of Level-3-and-above classified-protection networks and critical information infrastructure operators is set at once a year, and results of inspections already conducted by other competent authorities in the same year are reused to avoid duplicate checks.
    对网络安全等级保护第三级（含）以上网络运营者、关键信息基础设施运营者，每年开展一次日常性现场检查；本年度其他主管部门已开展的现场检查，公安机关复用检查结果、不再重复检查。
  • Algorithm security is a newly added inspection item: public security organs will check whether entities have implemented their primary responsibility for algorithm safety, including recommender-system management institutions and technical safeguards.
    算法安全是新纳入的重点检查内容：公安机关将核查被检查对象是否依法落实算法安全主体责任、建立健全算法推荐管理制度和技术措施。
  • Inspection methods now include online patrol, vulnerability scanning and, for city-level-and-above organs, remote penetration testing with three working days’ advance notice; technical support may be outsourced to qualified security service providers under police command.
    检查方式升级为线上巡查、漏洞扫描，设区的市级以上公安机关可开展漏洞探测、渗透性测试等远程检测（提前三个工作日告知），并可委托具备能力的网络安全服务机构在民警指挥下提供技术支持。
  • For enterprises, the message is that data security and personal-information protection duties are now subject to direct routine supervision by public security organs, alongside traditional duties such as record-filing of networked units, log retention and classified-protection compliance.
    对企业的直接含义是：联网备案、日志留存、等级保护等传统义务之外，数据安全与个人信息保护义务也将接受公安机关常态化直接监管，合规准备应提前完成。

China’s public security cyberspace inspection regime gets a major upgrade from 1 October 2026 | 公安机关网络空间安全监督检查新规：2026年10月1日起全面升级

Overview

On 6 August 2026, the Ministry of Public Security (MPS) published the Measures for Public Security Organs’ Supervision and Inspection of Cyberspace Security (公安机关网络空间安全监督检查办法) as Order No. 176, adopted at the second MPS ministerial meeting on 1 July 2026. The Measures take effect on 1 October 2026, at which point the 2018 Provisions on Public Security Organs’ Inspection of Internet Security (Order No. 151) are repealed. For any organisation operating online in China — including the China subsidiaries of foreign enterprises, data processors and app or platform operators — the change is more than a renaming exercise: it redefines what public security organs may inspect, whom they may inspect, and how often.

What changed: from “internet security” to “cyberspace security”

The most fundamental change is conceptual. The old 2018 rules governed “internet security” in the narrow sense of protecting externally facing online business. Order No. 176 defines cyberspace security as the sum of network security, data security and information security, and states that the measures apply to supervision and inspection of whether network operators, data processors, personal-information processors and others have performed their statutory security obligations.

The practical effect is that internal systems, business networks that are not open to the public, data warehouses and employee or customer personal-information repositories all fall within the inspection remit. Being “not an internet company” is no longer a defence: the Measures explicitly cover data processing and personal-information processing activities wherever they occur.

Eight categories of inspection targets

Article 6 lists eight categories of entities that public security organs may inspect according to operational need:

  1. Internet service providers — access, data centres, content delivery, domain services and information services;
  2. Public internet access providers;
  3. Network operators and their constructors and maintainers;
  4. Critical information infrastructure (CII) operators and their constructors and maintainers;
  5. Providers of network products and services;
  6. Data processors;
  7. Personal-information processors;
  8. Other entities lawfully subject to inspection.

Entities that have previously suffered a network or data security incident, or that were administratively penalised for failing to perform statutory security obligations without rectifying as required, are flagged for key-focus inspection. Foreign-invested companies that operate cloud, data, e-commerce or software businesses in China should assume they fall within categories 5 to 7.

What is inspected: eleven core items plus special-event items

Article 7 sets out eleven focal points for routine inspection, including whether the entity has:

  • completed networked-unit record-filing and reported access-provider and user information and changes;
  • established and implemented network, data and information security management institutions and operating procedures;
  • recorded and retained user registration information and internet activity logs as required;
  • performed classified-protection (MLPS) obligations — level-setting filing, level testing, build-and-rectify and self-inspection;
  • performed CII security-protection obligations;
  • adopted technical measures against computer viruses, cyber attacks and intrusions;
  • rectified security vulnerabilities and eliminated risks;
  • taken preventive measures against content that laws and regulations prohibit;
  • implemented its primary responsibility for algorithm security, including recommender-system management institutions and technical measures (new);
  • performed data-security and personal-information-protection obligations (now enforceable directly by public security organs);
  • provided technical support and assistance to public security organs for national security, counter-terrorism and crime investigation.

During major national security-protection task periods (for example, major summits or events), Article 8 adds special-purpose inspection items covering security plans, risk assessments, emergency-response plans and drills, and incident reporting.

How inspection happens: layered methods with burden-reduction safeguards

The Measures deliberately combine stronger methods with burden-reduction for businesses:

  • Online patrol (Article 4): information-patrol, information-audit capability testing and vulnerability scanning conducted in ways that do not disrupt normal operations. Information-audit capability tests require three working days’ advance notice.
  • Remote detection: city-level-and-above public security organs may carry out vulnerability probing and penetration testing on network facilities and systems other than CII, again with three working days’ notice, without interference, and with coordination notices to cyberspace-administration and industry authorities.
  • On-site inspection (Articles 5, 11–12): conducted by county-level-and-above organs at the operator’s main place of operations; at least two police officers with police ID and an inspection notice; measures include entering premises, questioning responsible persons, reviewing and copying relevant information, and viewing security-protection measures.
  • Frequency cap (Article 9): for operators of Level-3-and-above MLPS networks and CII operators, routine on-site inspection is limited to once a year; if another competent authority has already conducted an on-site inspection in the same year, the public security organ reuses those results rather than repeating the check.
  • Inter-agency coordination (Articles 9–10): for daily inspections in sectors with their own regulators (telecom, energy, transport, water, finance, defence science and industry), the relevant regulators and cyberspace-administration bodies are informed five working days in advance, and joint inspections are preferred where proposed. Nationwide multi-sector campaigns require approval from the Central Cyberspace Affairs Commission.
  • Outsourced technical support (Article 13): public security organs may commission qualified security service providers, who must act under police command, sign confidentiality commitments and be subject to background vetting where penetration testing is involved.

Outcomes and enforcement

Article 14 forbids charging fees or requiring the purchase of designated products. Where risk hidden dangers are found, organs direct rectification (Article 16). Where problems do not yet constitute illegal activity, the organ may issue a public-security reminder letter, send a letter to the competent industry authority, or publish a public notice without naming the entity (Article 17). Legal representatives or principal responsible persons of operators may be summoned for talks where significant risks or incidents exist (Article 19). Breaches of statutory duties are pursued under the Cybersecurity Law, the Data Security Law, the Personal Information Protection Law, the CII Security Protection Regulations, the Network Data Security Administration Regulations and related rules (Article 16). Information obtained during inspection may be used only for cyberspace-security purposes and must be kept confidential (Article 20).

Practical steps for foreign-invested companies

  • Treat 1 October 2026 as a compliance deadline. Run an internal gap assessment before the Measures take effect, covering MLPS level-setting and testing validity, log retention, vulnerability management and the completeness of security-management documentation.
  • Extend the compliance scope to data and personal information. Document data classification and grading, important-data protection measures, risk assessments and personal-information-protection impact assessments, because these duties are now directly inspectable by public security organs rather than being treated as cyber-office-only matters.
  • Review algorithm practices. If the business operates content recommendation, search or ranking algorithms, confirm that algorithm primary-responsibility institutions and recommender-management technical safeguards are in place and properly documented.
  • Prepare an inspection kit. Designate a responsible manager and point of contact for inspections; keep complete records of record-filing certificates, testing reports, rectification logs, incident and drill records.
  • Leverage the coordination safeguards. If another regulator (e.g. the Cyberspace Administration of China or an industry authority) has already inspected the entity this year, be ready to cite that inspection to avoid duplicate on-site checks.
  • If a security firm is engaged by the authority, co-operate under the rules: technical supporters act under police command and must sign confidentiality commitments covering trade secrets and personal information.

Sources

  • 中国网（据公安部网站消息）— 网安监督检查新规明确检查内容等 10月1日起施行: https://news.china.com.cn/2026-08/07/content_118638649.shtml
  • 安全内参 — 《公安机关网络空间安全监督检查办法》出台，企业合规面临哪些新变化?: https://www.secrss.com/articles/92931
  • 微博专栏（2026年8月国内网络安全领域重要政策及标准速览，收录176号令要点）: https://weibo.com/ttarticle/p/show?id=2309405339428934779056

Related reading

  • see also: how MLPS and CII obligations apply to foreign-invested enterprises (37-cybersecurity-mlps-fie)

公安机关网络空间安全监督检查新规：2026年10月1日起全面升级

概述

2026年8月6日，公安部公布《公安机关网络空间安全监督检查办法》（公安部令第176号）。该办法已于2026年7月1日经公安部第2次部务会议审议通过，自2026年10月1日起施行，2018年发布的《公安机关互联网安全监督检查规定》（公安部令第151号）同时废止。对任何在中国境内开展线上业务的组织——包括外资企业在华子公司、数据处理者、APP与平台运营者——这次调整不是简单的改名：它重新定义了公安机关可以检查什么、检查谁、多久查一次。

变化核心：从”互联网安全”到”网络空间安全”

最根本的变化在理念层面。旧版2018年规则治理的是狭义”互联网安全”，即对外在线业务防护。176号令把网络空间安全定义为网络安全、数据安全、信息安全三者的总和，并明确本办法适用于对网络运营者、数据处理者、个人信息处理者等履行法定安全义务情况开展的监督检查。

实际效果是：内网系统、不对公开放网的业务系统、数据仓库、员工或客户个人信息库，全部落入监管视野。”我们不是互联网公司”不再是挡箭牌——办法明确覆盖一切数据与个人信息处理活动，无论其发生在何处。

八类检查对象

第六条规定，公安机关可根据维护网络空间安全需要，对以下对象依法开展监督检查：

  1. 提供互联网接入、数据中心、内容分发、域名服务、信息服务等的互联网服务提供者；
  2. 公共上网服务提供者；
  3. 网络运营者及其建设者、维护者；
  4. 关键信息基础设施运营者及其建设者、维护者；
  5. 网络产品、服务的提供者；
  6. 数据处理者；
  7. 个人信息处理者；
  8. 其他依法可以监督检查的对象。

曾发生网络安全、数据安全等事件，或曾因未履行法定义务被行政处罚且未按要求整改的，列为重点监督检查对象。在华从事云、数据、电商或软件业务的外资企业，应默认自身落在第5至第7类范围内。

查什么：十一项重点内容加重大活动专项

第七条列出日常检查十一项重点，包括是否：依法办理联网单位备案并报送接入单位和用户信息及变更情况；依法制定并落实网络、数据、信息安全管理制度和操作规程；依法记录并留存用户注册信息和上网日志；依法履行等级保护（定级备案、等级测评、建设整改、自查）；依法履行关键信息基础设施安全保护义务；依法采取防范病毒、攻击、入侵的技术措施；针对漏洞隐患采取整改措施；依法对法律法规禁止发布或传输的信息采取防范措施；依法落实算法安全主体责任、建立健全算法推荐管理制度和技术措施（新增）；依法履行数据安全与个人信息保护义务（现由公安机关直接监管）；依法为国家安全、反恐、侦查犯罪提供技术支持与协助。

在国家重大安全保卫任务期间，第八条增加专项检查内容，覆盖安保工作方案与责任分工、风险评估与风险管控、应急预案与演练、应急设施有效性及事件报告处置情况。

怎么查：多元手段叠加”减负”机制

办法有意把更强的手段与为企业减负的制度结合起来：

  • 线上巡查（第四条）：网络信息巡查、信息审核能力测试、漏洞扫描等不影响正常业务运行的方式。开展信息审核能力测试须提前三个工作日告知。
  • 远程检测：设区的市级以上公安机关可通过漏洞探测、渗透性测试，对关键信息基础设施以外的网络设施和信息系统进行远程检测，同样提前三个工作日告知，不得干扰破坏，并通报同级网信与行业主管部门。
  • 现场检查（第五、十一、十二条）：由运营机构所在地县级以上公安机关实施；民警不少于二人并出示警官证与监督检查通知书；措施包括进入场所、问询负责人、查阅复制信息、查看安全保护技术措施运行情况、开展技术检测。
  • 频次上限（第九条）：对等保三级（含）以上网络运营者与关基运营者，日常性现场检查每年一次；本年度其他主管部门已现场检查的，公安机关复用结果、不再重复检查。
  • 跨部门协同（第九、十条）：对电信、能源、交通、水利、金融、国防科技工业等行业开展日常性现场检查，应提前五个工作日告知网信与行业主管部门，对方提出联合检查的应联合开展；公安部部署跨行业跨部门检查须报中央网络安全和信息化委员会审批。
  • 委托技术支持（第十三条）：公安机关可委托具备能力的网络安全服务机构或专门人员提供技术支持，受托方须在民警指挥下开展工作、签署保密承诺书；涉及渗透测试的机构及人员须经背景审查并全流程安全管理。

结果运用与法律责任

第十四条禁止向被检查对象收取费用或要求购买指定产品服务。发现风险隐患的，督促指导整改（第十六条）。问题尚不构成犯罪的，可发放公安提示函、向行业主管部门发函或向社会发布不点名通告（第十七条）。存在较大风险或发生安全事件的，可对法定代表人、主要负责人进行约谈（第十九条）。未履行法定义务的，依据《网络安全法》《数据安全法》《个人信息保护法》《关键信息基础设施安全保护条例》《网络数据安全管理条例》等追究法律责任（第十六条）。检查获取的信息只能用于维护网络空间安全之目的，并须保密（第二十条）。

外资企业实务建议

  • 把2026年10月1日当作合规时点。 在办法施行前完成内部差距评估，覆盖等保定级与测评有效性、日志留存、漏洞闭环整改、安全管理制度文档完整性。
  • 把合规范围扩展到数据与个人信息。 数据分类分级、重要数据保护措施、风险评估、个人信息保护影响评估等文档要备齐，因为上述义务现在由公安机关直接检查，不再是”网信部门的事”。
  • 审查算法实践。 若经营内容推荐、搜索或排序算法业务，确认算法安全主体责任机构与推荐管理技术措施到位并可举证。
  • 准备迎检资料包。 指定责任人与迎检对接人；备案证书、测评报告、整改记录、事件与演练记录等完整留存。
  • 善用协同减负机制。 若本年度网信部门或行业主管部门已检查过，准备引用检查结论以避免重复现场检查。
  • 配合技术支持机构时注意边界。 受托机构在民警指挥下工作并签保密承诺书，涉商业秘密与个人信息事项须谨慎配合。

来源

  • 中国网（据公安部网站消息）— 网安监督检查新规明确检查内容等 10月1日起施行: https://news.china.com.cn/2026-08/07/content_118638649.shtml
  • 安全内参 — 《公安机关网络空间安全监督检查办法》出台，企业合规面临哪些新变化?: https://www.secrss.com/articles/92931
  • 微博专栏（2026年8月国内网络安全领域重要政策及标准速览，收录176号令要点）: https://weibo.com/ttarticle/p/show?id=2309405339428934779056

相关阅读

  • 见：外资企业的等保与关基义务如何适用（37-cybersecurity-mlps-fie）
E-commerce Entry / 电商入华

SAMR moves to clean up mini-program e-commerce: the Compliance Guidelines for Network-Transaction Mini-Program Platforms

  • On 1 September 2026, SAMR published the Compliance Guidelines for Network-Transaction Mini-Program Platforms (draft for comments, 19 articles) and invited feedback until 8 September 2026.
    2026年9月1日，市场监管总局就《网络交易小程序平台合规指引（征求意见稿）》公开征求意见，意见反馈截止日期为2026年9月8日；指引共19条。
  • The draft defines the mini-program platform operator as the party that provides application-distribution services through an information platform enabling trading parties to transact independently, and requires it to verify and register the identity, address, contact and administrative-licence information of mini-program operators, refreshing verification at least every six months.
    征求意见稿界定”小程序平台经营者”为通过信息平台向网络交易小程序提供应用程序分发服务、供交易双方或多方独立开展交易活动的网络平台经营者，并要求其对申请入驻的小程序经营者提交的身份、地址、联系方式、行政许可等真实信息进行核验、登记、建档，至少每六个月核验更新一次。
  • Platforms must not delete or otherwise interfere with consumers’ normal reviews of goods or services sold through mini-programs, and must maintain a review mechanism plus convenient complaint channels; operators exiting the platform must publish notice at least 30 days in advance, and platforms must keep their identity records for at least three years after exit.
    平台不得删除或以其他方式干预消费者对小程序所售商品或服务的正常评价，须健全消费者评价规则与便捷投诉渠道；小程序经营者退出平台须提前三十日公示，平台对其身份信息自退出之日起保存不少于三年。
  • The drafting note acknowledges the compliance gap behind chaotic mini-program e-commerce: platforms such as WeChat and Alipay have argued that since they do not take a cut of or profit from mini-program transactions and hold no transaction data, they owe no more than the duties of a technical-service provider; the Guidelines close that gap by making platform primary responsibility explicit.
    起草说明点明小程序交易乱象的制度根源：微信、支付宝等平台以”不从交易中抽成或获利、不掌握交易数据”为由主张仅承担技术服务提供者义务；指引通过明确平台主体责任来填补这一空白。
  • For foreign brands selling through mini-programs in China — via their own mini-programs or through third-party sellers — the takeaway is that the entire distribution chain is becoming more formal: identity verification, information display, inspection and monitoring, consumer-review integrity and complaint handling will now be supervised through the platform, and overseas sellers operating mini-programs on Chinese super-apps should align with e-commerce-operator duties.
    对通过小程序在华销售的外资品牌（自营小程序或第三方卖家）而言，信号是整条分发链走向规范化：身份核验、信息公示、检查监控、评价真实性与投诉处理将通过平台被监管；在中国超级应用上运营小程序的境外卖家应主动对齐电子商务经营者义务。

SAMR moves to clean up mini-program e-commerce: the Compliance Guidelines for Network-Transaction Mini-Program Platforms | 小程序电商”补课”：市场监管总局出台网络交易小程序平台合规指引

Overview

On 1 September 2026, the State Administration for Market Regulation (SAMR) published the Compliance Guidelines for Network-Transaction Mini-Program Platforms (《网络交易小程序平台合规指引（征求意见稿）》) for public comment, with feedback due by 8 September 2026. The draft responds to a visible regulatory hole in China’s platform economy: mini-program e-commerce — buying and selling done inside WeChat, Alipay, Douyin and similar super-apps without downloading a separate application — has boomed but has also produced malicious marketing, weak after-sales protection and consumer-harm cases, in part because the hosting platforms’ management responsibilities over the mini-program sellers were never clearly defined.

Who is regulated

The draft defines three concepts:

  • Network-transaction mini-program platform operator (小程序平台经营者): a network-platform operator that, through an information platform, provides application-distribution services to network-transaction mini-programs so that trading parties can independently conduct transactions. In practice this covers WeChat, Alipay, Douyin and other platforms that host commercial mini-programs.
  • Network-transaction mini-program (网络交易小程序): an application developed on an open-application-program interface through which users can buy goods or services without downloading or installing an app.
  • Network-transaction mini-program operator (网络交易小程序经营者): the natural person, legal person or unincorporated organisation that sells goods or provides services through such a mini-program. Where such an operator itself qualifies as a “network-transaction platform operator” under the Measures for the Supervision and Administration of Network Transactions, it must perform the corresponding duties under those Measures.

The Guidelines apply within China to platform operators providing network-platform services for mini-program transactions and to operators transacting through mini-programs.

Core platform duties

1. Identity verification (Article 4). Platforms must require mini-program operators seeking admission to submit genuine identity, address, contact and administrative-licence information; verify, register and file it; and refresh verification at least every six months. Platforms must not provide services to operators that have not lawfully obtained required administrative licences. Re-entering operators must pass the same checks.

2. Service agreements and trading rules (Article 5). Platforms must formulate and publicise service agreements and trading rules covering admission and exit, information review, goods and services, marketing-information management, consumer-rights protection and personal-information protection. Amendments require public consultation and at least seven days’ public notice before implementation (longer for major changes); all historical versions for the three years before an amendment takes effect must be preserved and accessible.

3. Information display (Article 6). Mini-program operators must continuously display their business-licence information, relevant administrative-licence information, or the link identifiers on their homepage or main business page. Platforms must establish management institutions for such display, provide technical support, and verify and update within seven working days when operators report changes (which they must do within three working days of any change).

4. Credit building (Article 7). Platforms are encouraged to differentiate management and services based on credit status derived from regulatory records (registration, filings, licences, spot-check results, administrative penalties, operation-anomaly lists, serious-lawbreaking lists), platform-held transaction and complaint data, consumer reviews and third-party credit information — and to warn consumers via labelling or pop-ups about operators on anomaly or serious-breaches lists.

5. Inspection and monitoring (Article 8). Platforms must establish inspection and monitoring over mini-program operators and their published goods/service information, covering at least: sale or supply of goods or services prohibited by law; false or misleading commercial publicity; sale of counterfeit or shoddy goods; and other illegal operations. Platforms may raise inspection frequency for high-risk or low-credit operators. Where the mini-program operator is itself a platform, the hosting platform must push it to run equivalent checks over its own tenants.

6. Handling measures (Article 9). On finding violations, platforms must take necessary measures, keep records and report to authorities; measures such as warnings, suspension or termination of service must be publicised within one working day; objections must be handled and answered promptly.

7. Mini-program exit (Article 10). Platforms must build exit mechanisms that protect consumers. An operator voluntarily terminating services must publicise notice on its mini-program homepage at least 30 days in advance and take reasonable measures to protect consumers and other operators; platforms must retain the operator’s identity information for at least three years after exit.

8. Compliance management, reviews, complaints, quality and reporting (Articles 11–15). Platforms are encouraged to appoint compliance directors and administrators; must build consumer-review rules and must not delete or otherwise interfere with normal consumer reviews; must provide convenient complaint channels and handle them promptly in co-ordination with market-regulation departments and consumer associations; are encouraged to build quality-management and risk-warning systems; and must report mini-program-operator identity information to the provincial market-regulation department where their registered address is located each January and July (with automated data-interface reporting encouraged).

9. Co-operation duty (Article 16). Platforms must promptly assist market-regulation departments in investigating illegal transactions and provide data in their possession.

The compliance-gap story behind the Guidelines

The drafting note is candid about why mini-program e-commerce has been disorderly: low entry barriers and high operational autonomy produce more violation risk than classic e-commerce platforms, and a principal reason is that hosting platforms have not borne management responsibility over the mini-program sellers. Platforms have argued that they do not take a cut of or profit from mini-program transactions, do not hold transaction data, and therefore should not bear obligations beyond those of a technical-service provider. The Guidelines reject that framing, setting platform duties that match platforms’ technical capability and actual operational model.

What this means for foreign brands selling through mini-programs

  • Expect heavier platform onboarding and periodic reverification. If your brand sells through a mini-program (own or third-party operated), the hosting platform will collect, verify and refresh your identity, licence and contact data every six months. Keep Chinese business-licence and licence documents current and centrally managed.
  • Consumer reviews become protected data. Deleting or curating negative reviews — directly or via incentives — will breach platform rules that mirror national law; review-management practices should be audited now.
  • Exit and entry discipline applies. If you plan to close a China mini-program channel, 30 days’ advance public notice and post-exit record retention are required; plan closures accordingly to avoid compliance surprises.
  • Data reporting is now structured. Platforms must report operator identity lists to provincial market-regulation authorities twice a year; make sure your registered identity data with the platform is accurate, because it will feed regulator databases.
  • Cross-border sellers using Chinese super-apps should review their status. An overseas company operating a mini-program in China may be treated as a network-transaction operator with e-commerce-operator duties (registration, information display, after-sales); where thresholds for market-subject registration do not apply, self-declaration mechanisms in the guidelines still require accurate filing.

Practical steps

  • Verify the identity and licence information your brand holds with each Chinese mini-program hosting platform, and set a six-month calendar for updates.
  • Audit consumer-review management: remove any process that deletes, filters or incentivises suppression of genuine reviews.
  • Review mini-program marketing content against the false-publicity prohibitions; retain evidence of claims.
  • Establish a point of contact for platform compliance requests and for market-regulation queries routed through platforms.
  • Submit comments on the draft before 8 September 2026 if your business model is affected, and track the final version expected in late 2026.

Sources

  • 市场监管总局 — 关于公开征求《网络交易小程序平台合规指引（征求意见稿）》意见的公告（含全文与起草说明）: https://www.samr.gov.cn:8007/hd/zjdc/art/2026/art_68686f054fe043b6b62c21f50e230b79.html
  • 中新经纬（新浪转载）— 事关网络交易小程序平台合规，官方征意见：不得删除消费者正常评价: https://k.sina.com.cn/article_5953189932_162d6782c06704wu1u.html
  • 央广网（手机央广转载）— 如何规范小程序交易乱象？新规征求意见: https://so.html5.qq.com/page/real/search_news?docid=70000021_0016a97dc7514352

小程序电商”补课”：市场监管总局出台网络交易小程序平台合规指引

概述

2026年9月1日，市场监管总局就《网络交易小程序平台合规指引（征求意见稿）》向社会公开征求意见，反馈截止日期为2026年9月8日。征求意见稿回应中国平台经济中一个显眼的监管空白：小程序电商——在微信、支付宝、抖音等超级应用内无需下载独立App即可完成的买卖——快速膨胀的同时，也伴生恶意营销、售后缺位、侵害消费者权益等乱象，部分原因在于承载平台对小程序卖家的管理责任从未被清晰界定。

监管谁

征求意见稿界定三个概念：

  • 网络交易小程序平台经营者（小程序平台经营者）：通过信息平台向网络交易小程序提供应用程序分发服务，供网络交易双方或多方独立开展交易活动的网络平台经营者。实操上即微信、支付宝、抖音等承载经营性小程序的平台。
  • 网络交易小程序：基于应用程序开放平台接口开发的，用户无需下载、安装应用程序即可进行商品或服务交易的经营性互联网应用程序。
  • 网络交易小程序经营者：通过小程序销售商品或提供服务的自然人、法人和非法人组织。若其本身属于《网络交易监督管理办法》所称网络交易平台经营者，则须依法履行相应义务。

指引适用于在中华人民共和国境内为小程序交易提供网络平台服务的小程序平台经营者，以及通过小程序开展交易的经营者。

平台核心义务

一、资质信息审核责任（第四条）。 平台应要求申请入驻的小程序经营者提交身份、地址、联系方式、行政许可等真实信息，核验、登记、建档，并至少每六个月核验更新一次；不得为未依法取得行政许可的经营活动提供服务；退出后再次申请入驻的仍须审核。

二、平台协议及交易规则（第五条）。 平台应制定并公示服务协议与交易规则，明确准入退出、信息审核、商品服务、营销信息管理、消费者权益保护、个人信息保护等权利义务。修改须公开征求意见，且至少在实施前七日公示（重大修改适当延长）；修改生效之日前三年的全部历史版本须完整保存并可阅览下载。

三、信息公示责任（第六条）。 小程序经营者应在小程序首页或经营主页面持续公示营业执照、行政许可信息或链接标识。平台应建立公示管理制度、提供技术支持并督促执行；信息变更后经营者三个工作日内报送、平台七个工作日内核验更新。

四、信用建设（第七条）。 鼓励平台根据监管注册登记、备案、许可、抽查检查、行政处罚、经营异常名录、严重违法失信名单等信息以及平台掌握的交易售后投诉数据、消费者评价与第三方信用信息，实施差别化管理和服务；对列入异常名录、失信名单、投诉较多的经营者，鼓励打标或弹窗提醒消费者。

五、检查监控制度（第八条）。 平台应对小程序经营者及其商品服务信息建立检查监控，至少覆盖：是否销售或提供法律禁止交易的商品服务、是否作虚假或引人误解宣传、是否销售假冒伪劣商品、是否存在其他违法违规经营。高风险低信用经营者可提高检查比例或频次；小程序经营者本身是平台的，承载平台应督促其对其平台内经营者同样建立检查监控。

六、处理措施（第九条）。 发现违法信息的，依法采取必要处置措施、保存记录并报告；警示、暂停或终止服务等处理措施须在决定之日起一个工作日内公示，载明名称、违法行为与措施；经营者异议应及时处理回应。

七、小程序退出（第十条）。 平台应健全退出机制防止消费者权益受损。经营者自行终止服务或申请退出的，应提前三十日在主页面显著位置持续公示，并采取合理必要及时措施保障消费者与相关经营者权益；平台对退出经营者的身份信息保存时间自退出之日起不少于三年。

八、合规管理、评价、投诉、质量与报送（第十一条至第十五条）。 鼓励平台配备合规总监与合规管理员；平台应健全消费者评价规则、为消费者提供真实客观评价途径，且不得删除或以其他方式干预消费者对商品或服务的正常评价；应设置便捷投诉渠道并及时受理处置；鼓励建立质量安全风险预警与应急处置机制；应于每年一月和七月向住所地省级市场监管部门报送小程序经营者身份信息（鼓励开放数据接口自动化报送）。

九、配合责任（第十六条）。 平台应及时协助市场监管部门查处违法交易并提供掌握的数据信息。

指引背后的”合规缺口”叙事

起草说明坦承小程序电商失序的根源：相比传统电商平台，小程序电商准入门槛低、经营自主权大，违规风险更高；而乱象频现的主要原因之一是平台未承担对小程序经营者的管理责任。微信、支付宝等平台主张自身不从交易中抽成或获利、不掌握交易数据，不应承担超出技术服务提供者的义务。指引否定了这一框架，把平台责任设定在与平台技术能力和实际经营模式相匹配的水平上。

对外资品牌的意义

  • 平台入驻审核与定期复核将更严格。 无论自营还是第三方运营小程序，承载平台将每六个月收集、核验并刷新你的身份、许可与联系方式数据。请保持中国营业执照与许可文件最新并集中管理。
  • 消费者评价成为受保护数据。 删除或筛选差评——无论是直接删除还是通过激励——将违反与上位法呼应的平台规则；评价管理实践现在就该审计。
  • 退出与准入纪律适用。 若计划关闭在华小程序渠道，须提前三十日公示并保留退出后记录；提前规划关闭流程以避免合规意外。
  • 数据报送结构化。 平台每年两次向省级市场监管部门报送经营者身份名单；确保在平台登记的注册身份数据准确，因为它将进入监管部门数据库。
  • 使用中国超级应用的跨境卖家应审视自身定位。 在海外注册但在华运营小程序的公司，可能被认定为网络交易经营者并承担电子商务经营者义务（登记、信息公示、售后）；即使不满足市场主体登记门槛，指引中的自我声明机制仍要求准确申报。

实务建议

  • 核验品牌在每个中国小程序承载平台登记的身份与许可信息，设定每六个月的更新日历。
  • 审计消费者评价管理：移除任何删除、过滤或激励压制真实评价的流程。
  • 对照虚假宣传禁令审查小程序营销内容，留存宣传证据。
  • 建立对接平台合规请求以及经平台转来的监管问询的联系人。
  • 若业务模式受影响，在2026年9月8日前就征求意见稿提交意见，并跟踪预计2026年底出台的正式版。

来源

  • 市场监管总局 — 关于公开征求《网络交易小程序平台合规指引（征求意见稿）》意见的公告（含全文与起草说明）: https://www.samr.gov.cn:8007/hd/zjdc/art/2026/art_68686f054fe043b6b62c21f50e230b79.html
  • 中新经纬（新浪转载）— 事关网络交易小程序平台合规，官方征意见：不得删除消费者正常评价: https://k.sina.com.cn/article_5953189932_162d6782c06704wu1u.html
  • 央广网（手机央广转载）— 如何规范小程序交易乱象？新规征求意见: https://so.html5.qq.com/page/real/search_news?docid=70000021_0016a97dc7514352
FTZ Setup / 自贸区落地

Beijing links its FTZ policy pool to 11 zones outside the fence: the FTZ Linkage Development Zones Work Plan

  • In late August / early September 2026, Beijing’s “Two Zones” (Beijing FTZ + national comprehensive demonstration zone for further opening of the services sector) leading group printed and distributed the Work Plan on Building the Beijing FTZ Linkage Development Zones (document 两区〔2026〕1号, dated 6 August 2026).
    2026年8月底至9月初，”两区”工作领导小组印发《中国（北京）自由贸易试验区联动发展区建设工作方案》（两区〔2026〕1号，成文日期2026年8月6日），对外发布。
  • The Plan designates 11 linkage development zones with a total area of 119.20 square kilometres across seven districts hosting FTZ clusters (Haidian, Changping, Chaoyang, Shunyi, Tongzhou, Daxing, E-Town) and four further districts (Fengtai, Shijingshan, Mentougou, Huairou), anchored on four industries: medicine & health, artificial intelligence, integrated circuits and commercial aerospace.
    方案确定11个联动发展区、总面积119.20平方公里，覆盖海淀、昌平、朝阳、顺义、通州、大兴、亦庄七个自贸组团所在区及丰台、石景山、门头沟、怀柔四区，聚焦医药健康、人工智能、集成电路、商业航天四大产业。
  • The design is an “industry + region” linkage system: rather than replicating FTZ policies everywhere, each linkage zone is paired with specific FTZ clusters so that policy strengths (e.g. data cross-border flows, stem-cell and gene-therapy opening, biomedical special-items customs clearance) can spill over to businesses located outside the FTZ.
    方案首创”产业+区域”联动体系：并非在各地复制自贸政策，而是让各联动区与特定自贸组团结对，使数据跨境流动、干细胞与基因诊疗技术开发应用开放、生物医药特殊物品通关等政策红利外溢到区外企业。
  • For medicine & health, the Plan builds a “Changping R&D and pilot-testing — E-Town, Daxing and Mentougou manufacturing — Tongzhou medical-industry synergy — Huairou enablement and innovation validation — Shunyi trade circulation” chain, sharing review-and-approval, cross-border finance, foreign-related legal and IP services.
    医药健康领域构建”昌平研发中试—亦庄、大兴、门头沟智造—通州医产协同—怀柔赋能及创新验证—顺义贸易流通”联动体系，共享审评审批、跨境金融、涉外法律、知识产权等服务。
  • For foreign investors, the linkage zones are a location-strategy signal: companies in life sciences, AI, chips and aerospace that need Beijing FTZ-type openness but do not want to locate inside the FTZ now have a formal mechanism to tap the same policy pool, with zone-level co-ordination bodies to follow.
    对外资投资者而言，联动发展区是一个选址信号：需要北京自贸区式开放、又不愿把实体落在自贸区内的生命科学、人工智能、芯片与航天企业，如今有了接入同一政策池的正式机制，后续将建立区级协调机构。

Beijing links its FTZ policy pool to 11 zones outside the fence: the FTZ Linkage Development Zones Work Plan | 北京”政策破墙”：11个自贸联动发展区如何把自贸红利带给区外企业

Overview

In early September 2026, Beijing publicised the Work Plan on Building the China (Beijing) Pilot Free Trade Zone Linkage Development Zones (《中国（北京）自由贸易试验区联动发展区建设工作方案》), a document of the “Two Zones” leading group (两区〔2026〕1号, dated 6 August 2026). The Plan responds to a concrete problem: companies inside the Beijing FTZ enjoy institutional openness — data cross-border flows, opening of stem-cell and gene-therapy technology development and application, and customs facilitation for special biomedical items — while companies immediately outside, which often form the same industrial chain, do not. Rather than expanding the FTZ’s physical border, Beijing is building a linkage mechanism so that FTZ policy strengths spill over to chosen zones outside it.

The “industry + region” design

The Plan selects four industries with international competitiveness as the anchor: the trillion-yuan-class medicine & health sector, the hundred-billion-yuan-class AI and integrated-circuit sectors, and the future-industry commercial aerospace sector. It then defines 11 linkage development zones covering 119.20 square kilometres:

  • the seven districts that host FTZ clusters — Haidian, Changping, Chaoyang, Shunyi, Tongzhou, Daxing and E-Town (亦庄/Beijing Economic-Technological Development Area); and
  • four further districts — Fengtai, Shijingshan, Mentougou and Huairou.

Zones were chosen on the principles of “sound industrial base, strong policy demand, clear spatial boundaries and workable management mechanisms”. The core working method is institutional docking (制度对接), industrial interconnection (产业互联) and platform integration (平台融通) between the FTZ clusters and the linkage zones.

Four industry chains

Medicine & health. Anchored on the Changping and E-Town clusters with Shunyi as the trade hub, the Plan builds the chain “Changping R&D and pilot-testing — E-Town, Daxing and Mentougou intelligent manufacturing — Tongzhou medical-industry synergy — Huairou enablement and innovation validation — Shunyi trade circulation“. Concretely:

  • Changping linkage zone co-operates on R&D and pilot-testing for medicine & health and synthetic biology;
  • E-Town linkage zone handles commercialisation of science results and industrialisation co-ordination;
  • Daxing linkage zone shares drug and device manufacturing and review-and-approval resources;
  • Mentougou linkage zone provides cardiovascular innovative drug-device R&D and smart-manufacturing resources;
  • Tongzhou linkage zone deepens medical-industry integration;
  • Huairou linkage zone supplies basic research and validation-and-transformation support.

The Plan also calls for joint breakthroughs on core technology bottlenecks in innovative drugs, synthetic biology and high-end medical devices; shared laboratories, medical-device prototype workshops, large-science facilities and pilot bases; and shared services in review and approval, cross-border finance, foreign-related law and IP.

Artificial intelligence. Anchored on Haidian and E-Town, the chain runs “Haidian original innovation — Shijingshan humanoid-robot training — Shunyi intelligent-driving vehicle R&D — E-Town, Chaoyang, Fengtai and Mentougou application — Mentougou computing power”, with shared computing resources, a co-ordinated AI computing-power scheduling platform, high-quality industry datasets and intelligent annotation platforms.

Integrated circuits. The chain runs “Haidian design — E-Town and Shunyi manufacturing — Chaoyang optoelectronics — Huairou original innovation and testing”, with industry-university-research innovation consortia, expanded advanced-process chip supply, and shared hardware-emulation, testing-validation and optoelectronic-packaging platforms.

Commercial aerospace. The chain runs “Haidian constellation R&D — Fengtai satellite application services — E-Town rocket R&D — Shijingshan deep-space exploration”, with result-transformation and supply-demand matching mechanisms and shared public services for test validation, pilot transformation and prototype manufacturing.

Why the linkage zones exist

Beijing’s “Two Zones” office explains the motivation in three layers:

  • Beijing FTZ enterprises need partners outside the FTZ for R&D innovation, high-end equipment, public platforms and application scenarios;
  • companies outside the FTZ have strong demand for FTZ-type policies — data cross-border flows, openness of stem-cell and gene-therapy technology development and application, and customs clearance of special biomedical items;
  • the linkage zones serve as Beijing’s own higher-level autonomous opening, implementing the central document on upgrading the free-trade-pilot-zone strategy.

The result is a systematic answer to a common complaint of foreign and domestic high-tech firms: “the policy is across the street but not for us”.

What this means for investors

  • A formal route to FTZ-type policy without FTZ location. Companies that anchor R&D or manufacturing in Haidian, Daxing, Mentougou, Huairou and other linkage zones can expect the same review-and-approval, cross-border data and customs facilitation agenda to be extended through zone-level co-ordination — worth verifying case by case with the relevant district.
  • Life-sciences value chain re-mapping. The medicine & health chain maps clear roles: R&D and pilot-testing in Changping, manufacturing in E-Town/Daxing/Mentougou, medical-industry synergy in Tongzhou, validation support in Huairou, trade in Shunyi. Foreign drug and device firms planning Beijing operations can now choose a site by chain position rather than by proximity alone.
  • AI and chip players should watch computing and dataset platforms. Shared AI computing-power scheduling and industry-dataset/annotation platforms imply subsidised or co-ordinated infrastructure; firms whose work is compute-heavy should evaluate Mentougou and the co-ordination platforms.
  • Implementation pace will be district-specific. The Plan is framework-level; each linkage zone is expected to develop concrete implementation measures, project pipelines and service packages. Early movers engaging district authorities now may shape those packages.

Practical steps

  • Map your Beijing operations against the four chains to identify which linkage zone matches your activity.
  • Approach the relevant district’s “Two Zones” office to confirm which FTZ policy items have been (or will be) extended to the linkage zone and through which procedures.
  • For biomedical firms, review the stem-cell/gene-therapy and special-items customs facilitation pipeline, and whether your planned site can access the shared review-and-approval services.
  • For AI/chip firms, evaluate the shared computing, dataset and testing platforms as location or co-operation options.
  • Track each linkage zone’s implementation measures as they are released during late 2026.

Sources

  • 北京市人民政府门户网站 — “两区”工作领导小组关于印发《中国（北京）自由贸易试验区联动发展区建设工作方案》的通知（两区〔2026〕1号）: https://www.beijing.gov.cn/zhengce/zhengcefagui/202609/t20260904_4850659.html
  • 北京市商务局 — 《中国（北京）自由贸易试验区联动发展区建设工作方案》政策解读: https://sw.beijing.gov.cn/zwxx/2024zcjd/202609/t20260904_4850606.html
  • 央视网 — 设立11个自贸试验区联动发展区 协同布局四大重点产业: https://city.news.cctv.com/2026/09/01/ARTIsH2heuLNbNftPbkl2M9b260901.shtml
  • 人民网北京频道 — 北京划定11个自由贸易试验区联动发展区: https://bj.people.com.cn/n2/2026/0904/c14540-41686517.html

Related reading

  • see also: how FTZ setups work and typical incentives for foreign investors (ftz-setup-basics)
  • see also: Beijing’s services-sector opening and “Two Zones” agenda (beijing-two-zones-opening)

北京”政策破墙”：11个自贸联动发展区如何把自贸红利带给区外企业

概述

2026年9月初，北京对外发布《中国（北京）自由贸易试验区联动发展区建设工作方案》（两区〔2026〕1号，成文日期2026年8月6日）。方案回应一个具体难题：北京自贸区内企业享有制度型开放——数据跨境流动、干细胞与基因诊疗技术开发应用开放、生物医药特殊物品通关便利——而仅一街之隔、往往同处一条产业链的区外企业却享受不到。北京的选择不是扩大自贸区物理边界，而是建立联动机制，让自贸政策红利外溢到精选的区外区域。

“产业+区域”的设计

方案筛选出四大具有国际竞争力的产业作为联动核心：万亿级的医药健康、千亿级的人工智能与集成电路、未来产业的商业航天。据此确定11个联动发展区，总面积119.20平方公里：

  • 7个自贸组团所在区——海淀、昌平、朝阳、顺义、通州、大兴、亦庄；
  • 4个其他区——丰台、石景山、门头沟、怀柔。

选区的原则是”产业基础好、政策诉求强、空间边界清、管理机制顺”。核心工作方法是自贸组团与联动区之间的制度对接、产业互联、平台融通。

四条产业链

医药健康。 以昌平组团、亦庄组团为基点，顺义组团为枢纽，构建”昌平研发中试—亦庄、大兴、门头沟智造—通州医产协同—怀柔赋能及创新验证—顺义贸易流通“联动体系。具体分工：

  • 昌平联动区协同开展医药健康与合成生物产业研发中试；
  • 亦庄联动区承接科技成果落地与产业化协作；
  • 大兴联动区共享药品药械制造、审评审批资源；
  • 门头沟联动区提供心血管创新药械研发智造资源；
  • 通州联动区深化医产融合发展；
  • 怀柔联动区提供基础研究与验证转化支撑。

方案要求围绕创新药、合成生物、高端医疗器械开展协同攻关，共享实验室、医疗器械样机制作平台、大科学装置、中试基地，并提供审评审批、跨境金融、涉外法律、知识产权等服务。

人工智能。 以海淀组团、亦庄组团为基点，构建”海淀策源—石景山人形机器人训练—顺义智能驾驶汽车研发—亦庄、朝阳、丰台、门头沟应用—门头沟算力”联动体系，共享算力资源与平台设施，共建人工智能算力资源协同调度平台、高质量行业数据集和智能化标注平台。

集成电路。 构建”海淀设计—亦庄、顺义制造—朝阳光电—怀柔原始创新及测试”联动体系，组建产学研创新联合体，提升先进制程芯片规模化供给能力，共享公共硬件仿真平台、集成电路测试验证平台、光电芯片封装测试验证平台。

商业航天。 构建”海淀星座研发—丰台卫星应用服务—亦庄火箭研发—石景山深空探测”联动体系，建立研发成果转化与供需对接机制，共享试验验证、中试转化、打样制造等全链条公共服务。

为什么要设联动发展区

北京”两区”工作领导小组办公室从三个层面解释动因：

  • 自贸区内企业在研发创新攻坚、高端设备配套、公共平台共享、应用场景拓展上需要与区外企业协作；
  • 区外企业对数据跨境流动、干细胞与基因诊疗技术开发和应用开放、生物医药特殊物品通关等政策需求强烈；
  • 设立联动区是落实《中共中央、国务院关于实施自由贸易试验区提升战略的意见》、服务全产业链创新发展、探索更高水平自主开放的重要抓手。

方案系统回应了内外资高科技企业的常见抱怨：”政策就在街对面，但不适用于我们。”

对投资者的意义

  • 不落自贸区也能接入自贸政策池的正式通道。 把研发或制造布局在海淀、大兴、门头沟、怀柔等联动区的企业，可望通过区级协调获得与自贸区同向的审评审批、跨境数据与通关便利——具体条目与程序需与所在区逐一核实。
  • 生命科学价值链重新布局。 医药健康链的角色划分清晰：昌平做研发中试、亦庄/大兴/门头沟做智造、通州做医产协同、怀柔做验证支撑、顺义做贸易。计划布局北京的外资药械企业可按链上位置选址，而非只看远近。
  • AI与芯片企业应关注算力与数据平台。 共享算力调度、行业数据集与标注平台意味着有组织的基础设施供给；算力密集型企业应评估门头沟及协同平台。
  • 落地节奏因区而异。 方案是框架性的；各联动区将出台具体实施办法、项目清单与服务包。现在与区级部门接洽的先行者可能影响这些配套的成型。

实务建议

  • 对照四条产业链梳理自身北京业务，判断匹配哪个联动区。
  • 联系所在区”两区”办，确认哪些自贸政策条目已（或将）延伸到联动区、通过何种程序。
  • 生物医药企业核查干细胞/基因治疗与特殊物品通关便利管线，确认计划选址能否接入共享审评审批服务。
  • AI与芯片企业把共享算力、数据集与测试平台作为选址或合作选项评估。
  • 跟踪2026年下半年各联动区陆续发布的实施办法。

来源

  • 北京市人民政府门户网站 — “两区”工作领导小组关于印发《中国（北京）自由贸易试验区联动发展区建设工作方案》的通知（两区〔2026〕1号）: https://www.beijing.gov.cn/zhengce/zhengcefagui/202609/t20260904_4850659.html
  • 北京市商务局 — 《中国（北京）自由贸易试验区联动发展区建设工作方案》政策解读: https://sw.beijing.gov.cn/zwxx/2024zcjd/202609/t20260904_4850606.html
  • 央视网 — 设立11个自贸试验区联动发展区 协同布局四大重点产业: https://city.news.cctv.com/2026/09/01/ARTIsH2heuLNbNftPbkl2M9b260901.shtml
  • 人民网北京频道 — 北京划定11个自由贸易试验区联动发展区: https://bj.people.com.cn/n2/2026/0904/c14540-41686517.html

相关阅读

  • 见：自贸区落地机制与外资企业典型激励（ftz-setup-basics）
  • 见：北京服务业扩大开放与”两区”议程（beijing-two-zones-opening）