- The “Hong Kong/Macao medicine pass” (港澳药械通) had approved 162 innovative drugs and devices (71 drugs, 91 devices) across 71 designated hospitals in all nine GBA cities by late April 2026, serving over 17,000 patient-visits.
截至 2026 年 4 月底，”港澳药械通”已在九市 71 家指定医院获批 162 款创新药械（71 药品、91 器械），惠及超 1.7 万人次。- A January 2026 multinational-pharma GBA roundtable in Guangzhou gathered 15 global firms (J&J, Pfizer, AstraZeneca, Bayer, Novartis, AbbVie, Sanofi) and highlighted GBA as a strategic channel for foreign innovators.
2026 年 1 月广州举办的跨国药企大湾区行座谈会汇聚 15 家跨国药企（强生、辉瑞、阿斯利康、拜耳、诺华、艾伯维、赛诺菲），凸显大湾区作为外企创新战略通道的定位。- Real-world study (RWS) via the medicine pass lets foreign products enter GBA within roughly six months and build evidence for national registration.
借药械通开展真实世界研究，可使外资产品约 6 个月内进入大湾区，并为全国注册积累证据。- Qianhai has issued the nation’s first policy supporting Hong Kong/Macao and foreign-invested medical institutions, with 14 international medical institutions and 4,045 beds clustered there.
前海出台全国首个支持港澳及外商医疗机构集聚发展政策，已集聚 14 家国际化医疗机构、床位 4045 张。- The June 2026 “Action Plan for Stabilising and Optimising Foreign Investment” expands the wholly foreign-owned hospital pilot, already covering nine localities including Guangdong and Shenzhen.
2026 年 6 月《利用外资固稳促优行动方案》扩大外商独资医院试点，该试点已覆盖含广东、深圳在内的 9 地。- Cross-boundary medical data and ambulance transfer are now operational, with Shenzhen–Hong Kong medical-data channels transmitting over 6.79 million files in four months.
跨境医疗数据与转运已落地，深港医疗数据通道上线 4 个月传输超 679 万份文件。- Foreign investors should enter via the medicine pass for products, the FTZ hospital pilot for services, and RWS collaboration for evidence generation.
外资企业应通过药械通导入产品、借自贸区医院试点提供医疗服务、以真实世界研究合作生成证据。
Greater Bay Area 2026: foreign-investment opportunities in healthcare and cross-border medical services | 2026 大湾区：医疗健康产业外资机会（港澳药械通、跨境医疗服务）
Overview
Healthcare is one of the most attractive — and most regulated — sectors for foreign investors in the Greater Bay Area (GBA). Two forces converge in 2026. First, the “Hong Kong/Macao medicine pass” (港澳药械通) has matured from a regional pilot into a strategic channel that multinational innovators treat as part of their China strategy. Second, the policy environment for foreign-invested medical services — wholly foreign-owned hospitals, Hong Kong/Macao-invested institutions, cross-boundary care — is being actively widened. For a foreign healthcare group, the GBA is no longer just a sales market but a place to run clinical evidence, pilot cross-boundary care and anchor regional operations.
This article maps the 2026 opportunity across three layers: innovative drugs and devices via the medicine pass, foreign-invested and Hong Kong/Macao medical institutions, and cross-boundary medical services and data.
The medicine pass: from pilot to strategic channel
The 2026 multinational-pharma GBA roundtable, held in Guangzhou on 28 January 2026 and hosted by the Guangdong Development Reform Commission (Provincial GBA Office), brought together leaders from 15 multinationals — Johnson & Johnson, Pfizer, AstraZeneca, Bayer, Novartis, AbbVie, Sanofi and others — with Guangdong and nine-city governments. The message from firms was consistent: the GBA’s market potential and innovation ecosystem make it a strategic location, and the medicine pass is the fastest route for innovative products.
The pass has expanded sharply. The number of Hong Kong/Macao drugs and devices approved for use in the GBA rose from 48 in 2023 to 146 (another source cites 149) by early 2026, and designated medical institutions grew from 19 to 71, covering all nine GBA cities. By late April 2026 the approved total reached 162 innovative products (71 drugs, 91 devices), serving over 17,000 patient-visits. Guangdong has enacted the *Regulations of Guangdong Province on the Import of Hong Kong and Macao Drugs and Medical Devices in the Nine GBA Mainland Cities*, standardising filing and approval and raising efficiency.
For foreign innovators the decisive advantage is speed and evidence. Industry experts note that, versus the traditional registration path, products can clear the medicine-pass access process in as little as six months. Just as important, the pass supports real-world study (RWS): Guangdong has issued supporting policies allowing public hospitals to collaborate with firms on RWS and detailing the filing process. Seven multinationals have already run nine RWS projects with four GBA medical institutions. A notable case is Pfizer’s migraine drug rimegepant, whose prospective single-arm multi-centre RWS was completed in three months using Guangzhou’s rich clinical resources.
Foreign-invested and Hong Kong/Macao medical institutions
On the services side, Qianhai has issued what it describes as the nation’s first policy supporting the clustered development of Hong Kong/Macao and foreign-invested medical institutions, and is advancing a wholly foreign-owned hospital pilot. The cluster already comprises 14 international medical institutions with 4,045 beds, and overseas-patient visits grow over 10% annually. Under “talent connect”, Shenzhen’s first Hong Kong nurse registered to practise in Qianhai, six Hong Kong-style family-doctor studios opened, and 44 overseas medical experts are resident. Under “medicine connect”, the pass covers five tertiary hospitals in the cooperation zone with 60 approved items serving over 2,300 patient-visits. Under “ambulance connect”, cross-boundary transfer achieves “no-exit clearance, point-to-point direct” with transfer time cut by 80%.
The June 2026 *Action Plan for Stabilising and Optimising Foreign Investment* (MOFCOM, NDRC, MOF) explicitly supports studying and expanding the geographic scope of the wholly foreign-owned hospital pilot. The existing pilot covers nine localities — Beijing, Shanghai, Tianjin, Nanjing, Suzhou, Fuzhou, Guangdong, Shenzhen and the whole of Hainan island — and the plan signals further expansion. It also supports bringing more innovative drugs and devices into commercial insurance coverage and facilitating foreign-invested drugs into retail channels.
Cross-boundary medical services and data
Cross-boundary care is becoming operational. The University of Hong Kong–Shenzhen Hospital — a GBA cross-boundary medical benchmark — is among the first medicine-pass pilot hospitals, has introduced 34 international drugs and 18 devices serving over 7,500 patient-visits, and hosts nearly 100 Hong Kong-registered doctors. It runs a Futian port direct shuttle (one-hour cross-boundary) and has built one-stop cross-boundary diagnosis with multi-language service and direct insurance settlement.
Data and payment rails are being built. Shenzhen–Hong Kong medical-data cross-boundary security channels transmitted over 6.79 million medical files in four months. Under “payment connect”, Shenzhen’s first “medical insurance + commercial insurance” one-stop service centre supports overseas cards and digital RMB; six institutions connect to international insurers for instant settlement. Guangzhou’s ten measures on the medicine pass (issued 30 March 2026) add a quarterly Guangzhou–Hong Kong–Macao consultation mechanism, an RWS collaboration network, and support for commercial-insurance inclusion and cross-boundary electronic payment.
Practical pathways for foreign investors
- For innovative products: treat the medicine pass as a China strategy, not a regional sideline. Identify clinical-need products already approved in Hong Kong/Macao, file through designated hospitals, and pair access with an RWS plan to generate national-registration evidence.
- For services: use the Qianhai / Nansha / Hengqin platforms and the expanded wholly foreign-owned hospital pilot to establish or partner with international medical institutions; anchor on the “ten connect” model (institution, talent, medicine, service, ambulance, payment, data, education, guarantee, elderly care).
- For payers and insurers: build direct-billing and commercial-insurance links; the GBA is piloting “medical insurance + commercial insurance” one-stop settlement and cross-boundary e-payment.
- For evidence: collaborate with GBA hospitals on RWS; several multinationals already run such projects and the policy framework is explicit.
- Compliance: the pass is bounded to designated hospitals and approved indications; products still need national registration for nationwide scale, and data crossing must follow the negative-list and security-channel rules.
Sources
- 粤港澳大湾区为何对跨国药企形成”强磁场”？（南方Plus，2026-01-28）
- 生物医药下一个风口在哪？跨国药企湾区论道（广东省药监局，2026-01）
- “港澳药械通”遴选爆款：小切口打开外企进入中国的战略高地（研发客，2026-06-16）
- 世卫组织代表点赞深圳前海”十个融通”（腾讯新闻，含外商医疗机构数据）
- 稳外资新政发布 教育、金融、医药等成开放重点（新华网，2026-06-23）
- 全省国际医疗服务试点医院代表齐聚深圳（腾讯新闻，港大深圳医院数据）
Related reading
- see also: GBA cross-boundary professional talent recognition (article 136)
- see also: GBA foreign-invested enterprise tax and landing (article 135)
- see also: Vocational training and education opening for foreign investors (article 138)
2026 大湾区：医疗健康产业外资机会（港澳药械通、跨境医疗服务）
概述
医疗健康是粤港澳大湾区对外资最具吸引力也最受监管的领域之一。2026 年两股力量交汇。其一，”港澳药械通”已从区域试点成熟为跨国创新者视为中国战略一部分的通道。其二，外商投资医疗服务——外商独资医院、港澳资机构、跨境医疗——的政策环境正被主动拓宽。对外资医疗集团而言，大湾区已不仅是销售市场，更是开展临床证据、试点跨境诊疗、布局区域运营的落脚点。
本文从三个层面梳理 2026 年的机会：借药械通导入创新药械、外资与港澳资医疗机构、跨境医疗服务与数据。
药械通：从试点到战略通道
2026 年 1 月 28 日在广州举行的跨国药企大湾区行座谈会，由广东省发展改革委（省大湾区办）主办，汇聚强生、辉瑞、阿斯利康、拜耳、诺华、艾伯维、赛诺菲等 15 家跨国药企高层与广东及九市政府。企业方的信号一致：大湾区市场潜力与创新生态使其成为战略要地，药械通是创新产品最快的入口。
药械通扩容迅猛。获批在粤港澳大湾区内使用的港澳药品、医疗器械，从 2023 年的 48 个增至 2026 年初的 146 个（另一说 149 个），指定医疗机构由 19 家扩展至 71 家、覆盖九市；截至 2026 年 4 月底，获批创新药械达 162 款（71 药品、91 器械），惠及超 1.7 万人次。广东已出台《广东省粤港澳大湾区内地九市进口港澳药品医疗器械管理条例》，规范申报、优化流程、提升效率。
对外资创新者，决定性优势是速度与证据。行业专家指出，相较传统注册路径，产品借药械通可在约 6 个月内完成准入；同样重要的是，药械通支持真实世界研究（RWS）——广东已出台配套政策，允许公立医院与企业合作开展 RWS 并细化申报流程。已有 7 家跨国药企与 4 家大湾区医疗机构开展 9 项真实世界研究。典型案例是辉瑞偏头痛药物瑞美吉泮，借助广州丰富医疗资源，仅三个月即完成前瞻性单臂多中心真实世界研究。
外资与港澳资医疗机构
服务端，前海出台其称为全国首个的支持港澳及外商医疗机构集聚发展政策，并推进外商独资医院试点。该集聚区已汇集 14 家国际化医疗机构、床位 4045 张，境外人士就诊量年增超 10%。在”人才通”下，深圳首名香港护士在前海注册执业，开设 6 家港式家庭医生工作室，44 名境外医疗专家常驻；”药械通”覆盖合作区内 5 家三级医院、累计获批 60 件、服务超 2300 人次；”救护通”实现”无下车通关、点对点直达”，转运时间压缩 80%。
2026 年 6 月商务部、国家发改委、财政部印发的《利用外资固稳促优行动方案》明确支持研究扩大外商独资医院试点区域范围。现有试点覆盖北京、上海、天津、南京、苏州、福州、广东、深圳及海南全岛 9 地，方案释放进一步扩围信号；同时支持将更多创新药械纳入商业保险保障、便利外资企业生产的药品进入零售渠道。
跨境医疗服务与数据
跨境诊疗正走向可运营。香港大学深圳医院作为大湾区跨境医疗标杆，是首批药械通试点医院，已引进 34 种国际药品、18 种器械，惠及超 7500 人次，近 100 名港籍医生执业；开通福田口岸直达专线（跨境单程 1 小时），构建一站式跨境诊疗、多语种服务与保险直付。
数据与支付通道正在搭建。深港医疗数据跨境安全通道上线 4 个月传输医疗文件超 679 万份；”支付通”建成深圳首家”医保+商保”一站式服务中心，支持境外卡与数字人民币，6 家机构接入国际商保实现即时结算。广州 2026 年 3 月 30 日发布的药械通”十条措施”新增穗港澳季度会商机制、真实世界研究协同网络，并支持纳入商保与拓展跨境电子支付。
外资企业的实操路径
- 创新产品： 将药械通视为中国战略而非区域副线。识别已在港澳获批的临床急需产品，通过指定医院申报，并把准入与真实世界研究计划配对，为全国注册积累证据。
- 医疗服务： 借助前海/南沙/横琴平台与扩围的外商独资医院试点设立或与国际化医疗机构合作，锚定”十个融通”模式（机构、人才、药械、服务、救护、支付、数据、科教、保障、养老）。
- 支付与保险： 构建直付与商保链接；大湾区正试点”医保+商保”一站式结算与跨境电子支付。
- 证据生成： 与大湾区医院合作开展 RWS，已有多家跨国药企落地项目，政策框架明确。
- 合规： 药械通限定于指定医院与获批适应症；产品全国放量仍需国家注册，数据跨境须遵循负面清单与安全通道规则。
来源
- 粤港澳大湾区为何对跨国药企形成”强磁场”？（南方Plus，2026-01-28）
- 生物医药下一个风口在哪？跨国药企湾区论道（广东省药监局，2026-01）
- “港澳药械通”遴选爆款：小切口打开外企进入中国的战略高地（研发客，2026-06-16）
- 世卫组织代表点赞深圳前海”十个融通”（腾讯新闻，含外商医疗机构数据）
- 稳外资新政发布 教育、金融、医药等成开放重点（新华网，2026-06-23）
- 全省国际医疗服务试点医院代表齐聚深圳（腾讯新闻，港大深圳医院数据）
相关阅读
- 见：大湾区跨境专业人才资格互认（第 136 篇）
- 见：大湾区外商独资企业落地与税收优惠（第 135 篇）
- 见：外商投资职业教育与职业技能培训（第 138 篇）