Which agency regulates what for drugs, devices and health data in China

Four national bodies decide most of what a drug or device company meets in China. The National Medical Products Administration registers products. The National Healthcare Security Administration decides what insurance pays for and runs national procurement. The National Health Commission administers human genetic resources, and the Cyberspace Administration of China governs the export of personal information.¹²³⁴⁵

Subject	National body	Main instrument
Registration of drugs	National Medical Products Administration	Measures for the Administration of Drug Registration
Registration of devices	National Medical Products Administration	Measures for the Registration and Filing of Medical Devices
Reimbursement list and payment standards	National Healthcare Security Administration	Interim Measures for the Administration of Drugs under Basic Medical Insurance
Human genetic resources	Health department of the State Council	Regulations on the Administration of Human Genetic Resources
Personal information and its export	Cyberspace Administration of China	Personal Information Protection Law

The drug regulator

The National Medical Products Administration is a national bureau managed by the State Administration for Market Regulation. Its rank is vice-ministerial.¹ The provisions that set its functions took effect on 29 July 2018.¹

The administration is responsible for the safety supervision of drugs, medical devices and cosmetics. Its functions include the following.¹

• standards, including the national pharmacopoeia and device standards
• registration, with the rules for review and approval
• quality management rules for research, production, distribution and use
• risk management after marketing, including monitoring of adverse reactions and adverse events
• inspection, and action against violations at the registration stage
• guidance of the provincial drug regulators

The registration measures for drugs and for devices are orders of the State Administration for Market Regulation, the body that manages the administration.⁶⁷

Levels of regulator

The 2018 provisions divide licensing, inspection and penalties among three levels.¹

Level	Stage it handles
National Medical Products Administration	The regulatory system, and the research and development stage
Provincial drug regulators	Production, drug wholesale, the head offices of retail chains, and third-party platforms for online sales
Market regulators of cities and counties	Drug retail, device distribution, and quality in the use of drugs and devices

Technical bodies for drugs

The administration is in charge of drug registration nationwide. Technical work is done by bodies under it.⁶

Body	Work under the drug registration measures
Center for Drug Evaluation	Review of clinical trial applications, marketing applications, supplementary applications and re-registration of drugs produced abroad
National Institutes for Food and Drug Control	Registration testing
Center for Food and Drug Inspection	Registration inspection
Center for Drug Reevaluation	Suitability review of non-prescription drugs
Chinese Pharmacopoeia Commission	Approval of generic names

Provincial drug regulators handle five matters in drug registration.⁶

• re-registration of drugs produced in China
• filings and reports of changes after marketing
• routine supervision of non-clinical safety research institutions and clinical trial institutions
• taking part in inspection and testing organised by the national administration
• matters that the national administration entrusts to them

Technical bodies for devices

The administration organises review and approval of domestic Class III devices and of imported Class II and Class III devices. It also handles filing of imported Class I devices.⁷

The Center for Medical Device Evaluation carries out the technical review of those applications. It also reviews applications for the clinical trials that need approval.⁷

Level	Device work
Provincial drug regulators	Registration of domestic Class II devices, quality system inspection of domestic Class II and Class III devices, and supervision of clinical trials
Municipal regulators	Filing of domestic Class I devices

Reimbursement and procurement

The healthcare security department of the State Council sets the scope of drugs paid by basic medical insurance for the whole country. It draws up, adjusts and issues the national drug list and compiles the unified insurance codes.² Provincial healthcare security departments supervise how the list is carried out in their regions.²

The share that a patient pays first for a Category B drug is set by the province or the pooling region.²

An opinion of the General Office of the State Council gives the National Healthcare Security Administration the task of coordinating, supervising and guiding centralised volume-based procurement of drugs.⁵

Human genetic resources

The health department of the State Council is responsible for the administration of human genetic resources nationwide. Other departments of the State Council take part within their own duties.³ The regulations were amended by a decision of the State Council dated 10 March 2024.³

Provincial departments in charge of human genetic resources are responsible within their regions.³ The health department of the State Council also imposes the penalty on a foreign party that collects, stores, uses or exports Chinese human genetic resources in breach of the regulations.³

Personal information

The national cyberspace department coordinates the protection of personal information and the supervision related to it. Departments of the State Council are responsible within their own duties under the law.⁴ The duties of local departments at county level and above are set under national rules.⁴

The law calls these bodies together the departments performing personal information protection duties. Their duties include the following.⁴

• guiding and supervising personal information processors
• receiving and handling complaints and reports
• organising assessments of applications and publishing the results
• investigating and handling unlawful processing

How the bodies meet

The 2018 provisions set out how the drug regulator works with other departments.¹

Department	Shared matter
National Health Commission	The national pharmacopoeia, and mutual notice of major adverse reactions and adverse events
Ministry of Commerce	Plans and policies for drug distribution
Ministry of Public Security	Investigation of crimes involving drugs, devices and cosmetics

The drug regulator takes part in drawing up the national essential medicines list.¹ The insurance measures support the inclusion of qualifying essential medicines in the national drug list.²

Questions people also ask

Is the National Medical Products Administration part of the health ministry?

It is a national bureau managed by the State Administration for Market Regulation.¹

Who reviews a new drug application in China?

The Center for Drug Evaluation reviews marketing applications, clinical trial applications and supplementary applications.⁶

Who registers a Class II device made in China?

The provincial drug regulator reviews and approves domestic Class II devices.⁷

Which body administers human genetic resources?

The health department of the State Council is responsible nationwide.³

Who decides whether insurance pays for a drug?

The healthcare security department of the State Council draws up and adjusts the national drug list.²

Footnotes

1. Provisions on the Functions, Internal Bodies and Staffing of the National Medical Products Administration, in force from 29 July 2018, Articles 2 and 3. https://www.gov.cn/zhengce/2018-09/10/content_5320814.htm ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸

2. National Healthcare Security Administration, Interim Measures for the Administration of Drugs under Basic Medical Insurance, Order No. 1, Articles 6, 7 and 25. https://www.gov.cn/zhengce/zhengceku/2020-08/04/content_5532409.htm ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶

3. Regulations on the Administration of Human Genetic Resources, as amended by the State Council decision of 10 March 2024, Articles 4 and 41. https://www.nhc.gov.cn/qjjys/rlyczygl/202503/c5373f14621e4011b6cbc932184086a2/files/1746832760945_40292.pdf ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶

4. Personal Information Protection Law of the People’s Republic of China, Articles 60 and 61. https://www.cac.gov.cn/2021-08/20/c_1631050028355286.htm ↩ ↩² ↩³ ↩⁴

5. General Office of the State Council, Opinions on Making Centralised Volume-Based Procurement of Drugs Regular and Institutional, Guo Ban Fa [2021] No. 2, item 18. https://www.gov.cn/zhengce/content/2021-01/28/content_5583305.htm ↩ ↩²

6. Measures for the Administration of Drug Registration (State Administration for Market Regulation Order No. 27), Articles 5, 6 and 15. https://www.gov.cn/zhengce/zhengceku/2020-04/01/content_5498012.htm ↩ ↩² ↩³ ↩⁴

7. Measures for the Registration and Filing of Medical Devices (State Administration for Market Regulation Order No. 47), Articles 4 to 6. https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_568880e3ee344c45b38d073bba1c53ad.html ↩ ↩² ↩³ ↩⁴