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）