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NMPA Announcement No. 137 of 2024国家药监局 2024 年第 137 号公告

The Domestic Responsible Person境内责任人

If you hold an NMPA drug registration certificate and you are established outside China, you must appoint one. In force since 1 July 2025. This page sets out what the rule actually requires, article by article. 境外持有人取得 NMPA 药品注册证书，就必须指定境内责任人。规定自 2025 年 7 月 1 日起施行。本页逐条列出它到底要求什么。

The most common misreading最常见的误读

“Quality responsibility sits with the local partner.”“质量责任归本地合作方。”

That is the commercial logic of most in-licensing and distribution deals, and it is how the contracts usually read. The statute says something else. The Domestic Responsible Person bears joint and several liability with the marketing authorisation holder, and the overseas holder remains responsible for safety, efficacy and quality control throughout post-approval manufacture, distribution and use (Art. 2). The nine post-approval duties are performed jointly by both parties, not handed over (Art. 11). The holder is responsible for the authorisation and for managing any change of appointee, and has to keep that appointee performing for as long as the drug is on the market (Art. 12). 这是多数在许可与经销交易的商业逻辑，合同通常也这么写。但法条不是这么定的。境内责任人与药品上市许可持有人承担连带责任，境外持有人仍应当对药品上市后生产、经营、使用全过程的安全性、有效性和质量可控性负责（第二条）。九项上市后义务由两方共同履行，不是交接（第十一条）。境外持有人应当对其境内责任人的授权和变更管理负责，确保药品上市期间境内责任人持续履行义务（第十二条）。

A contract allocates the work. It does not move the liability.合同分配的是工作。它移不走责任。

Article 4第四条

Four conditions, all four required四项条件，须同时具备

The appointee must meet every one of these at the same time. A mailbox company does not qualify.境内责任人应当同时具备下列条件。一家空壳信箱公司不满足。

1

An enterprise legal person established inside China.在中国境内设立的企业法人。

2

A quality management system commensurate with performing the MAH's obligations.具有履行药品上市许可持有人义务相适应的质量管理体系。

3

Commensurate organisation and personnel, including dedicated staff independently responsible for drug quality management activities.具有相适应的机构人员，有专门人员独立负责药品质量管理活动。

4

Commensurate office premises.具有相适应的办公场所。

Where the appointee does not meet these conditions, the provincial regulator orders corrective action within a time limit; if it still does not meet them after that, sale and import are suspended (Art. 15).境内责任人不具备第四条条件的，省级药监部门督促限期整改；整改后仍不具备相应条件的，采取暂停销售、进口等措施（第十五条）。

Article 11第十一条

Nine duties, performed jointly九项义务，共同履行

The article opens with “the Domestic Responsible Person and the overseas holder jointly perform the following obligations”. Both parties, on all nine.条文开头是“境内责任人与境外持有人共同履行以下义务”。九项，两方都在里面。

  1. Drug quality and safety: establish a post-approval quality assurance system and maintain a continuing capability for quality assurance and risk control.负责药品质量安全，建立药品上市后质量保证体系，确保持续具备质量保证和风险控制能力。
  2. Establish and operate a drug traceability system, ensure the marketed drug is traceable, and provide traceability information as required.负责建立并实施药品追溯制度，确保相关上市药品可追溯，并按照规定提供追溯信息。
  3. Establish and operate an annual report system, reporting production and sales inside China, post-approval studies and risk management as required.负责建立并实施药品年度报告制度，按规定报告相关药品在中国境内的生产销售、上市后研究、风险管理等情况。
  4. Establish and operate systems for post-approval change and for drug re-registration, and process changes as required.负责建立并实施药品上市后变更、药品再注册管理制度，按规定办理变更事宜。
  5. Establish a pharmacovigilance system: monitor, identify, assess and control adverse reactions and other harmful reactions related to the use of the marketed drug.负责建立药物警戒体系，开展对已上市药品不良反应及其他与用药有关的有害反应的监测、识别、评估和控制。
  6. Handle post-approval recall and quality complaints, and report to the provincial regulator of its location as required.负责药品上市后召回、质量投诉处理等事宜，并按规定向所在地省级药品监督管理部门报告。
  7. Submit reference standards to the NIFDC as required, and actively cooperate with sampling inspection and lot release organised by the regulator.按规定向中国食品药品检定研究院提交标准物质，主动配合药品监督管理部门组织实施的抽检以及批签发等相关工作。
  8. Liaise with the overseas holder, and cooperate with regulators on site inspections, investigations and enforcement relating to the overseas holder.负责与境外持有人联络，配合药品监督管理部门开展对境外持有人相关的生产场地检查、调查和违法违规行为查处。
  9. Other obligations provided by laws and regulations.法律法规规定的其他义务。

Where the appointee fails to perform these duties and the imported drug may present a safety risk, the provincial regulator issues warnings, holds regulatory interviews, orders corrective action within a time limit, and suspends sale, use or import — and publishes the outcome (Art. 16). The trigger is possible risk, not proven harm.境内责任人未履行第十一条义务，导致进口药品可能存在安全隐患的，省级药监部门采取告诫、约谈、限期整改以及暂停销售、使用、进口等措施，并及时公布检查处理结果（第十六条）。触发条件是“可能存在”，不是已经出事。

The operational facts people miss容易漏掉的操作性事实

Art. 5
The appointment must be reported to the provincial regulator through the national drug business application system before the drug is first imported and sold, with the authorisation materials uploaded.应当在药品首次进口销售前，通过国家药品业务应用系统向所在地省级药监部门报告指定的境内责任人，并上传授权材料。
Art. 6
The authorisation package includes the original jointly signed undertaking of obligations and a notarised list of delegated responsibilities, plus named contacts and ID information on both sides. Reliable electronic signatures and seals have the same legal effect as wet ink.授权材料包括义务共签承诺书原件和经公证的授权责任清单，以及双方具名联系人与身份证件信息。符合法律规定的可靠电子签名、电子印章与手写签名或盖章具有同等法律效力。
Art. 7
One drug product, one Domestic Responsible Person. The same entity may however be appointed by different overseas holders for different imported products. Its name, address and contact details must appear in the package insert.单一药品品种只能指定唯一境内责任人；同一境内责任人可以接受不同境外持有人、不同进口药品品种的指定。其名称、地址、联系方式应当在药品说明书中列出。
Art. 8
A change of appointee must be reported within 15 working days of the authorisation taking effect, to the provincial regulator of the new location. Changes of address or contact details are reported promptly. The prior year's changes go into the annual report.变更境内责任人的，自授权书生效后 15 个工作日内向变更后所在地省级药监部门报告；地址或联系方式变更应及时报告；上一年的变更情况须在年度报告中报告。
Art. 13
At first import filing, the port drug administration checks whether the package insert states the Domestic Responsible Person. This is a customs-stage gate, not a paperwork formality.进口药品首次办理进口备案时，口岸药品监督管理局应当查验说明书是否载明境内责任人信息。这是通关环节的闸口，不是走过场。
Art. 10
NMPA publishes information on Domestic Responsible Persons and the public has the right to consult it. Your arrangement is visible.国家药监局负责对境内责任人的有关信息予以公开，公众有权查阅。你的安排是公开可见的。

Where SinoReg sitsSinoReg 的位置

What we do not do我们不做的

We do not act as your Domestic Responsible Person, and we accept no joint and several liability under Art. 2. Any adviser who offers to be both your assessor and your appointee is on both sides of the same question.我们不充当你的境内责任人，不承担第二条项下的连带责任。一家既做评估方又做被指定方的顾问，站在同一个问题的两边。

What we do我们做的

Readiness assessment against Art. 4 and Art. 11 before you sign: whether a candidate entity can actually perform the nine duties, what the authorisation package has to contain, and how the appointment lines up with your re-registration calendar. Every conclusion traced to the primary text.签字之前，按第四条与第十一条做准备度评估：候选主体到底能不能履行这九项义务、授权材料该包含什么、这次指定与你的再注册日历怎么对齐。每一条结论都回到一手条文。

Talk to us联系我们 Re-registration date lookup再注册日期查询

Source来源

Everything on this page comes from the full text of the Interim Provisions on the Appointment of Domestic Responsible Persons by Overseas Drug Marketing Authorisation Holders, Annex 1 to NMPA Announcement No. 137 of 2024, in force 1 July 2025. Article numbers are given inline so you can check each statement against the original. The NMPA text governs; this page is a reading of it, not a substitute for it, and it is not regulatory advice for any specific product. 本页内容全部出自《境外药品上市许可持有人指定境内责任人管理暂行规定》（国家药监局 2024 年第 137 号公告附件 1）全文，自 2025 年 7 月 1 日起施行。条号逐句标出，便于逐条回查原文。以 NMPA 原文为准；本页是对它的解读，不能替代原文，也不构成针对任何具体产品的监管意见。