China’s State Food and Drug Administration (CFDA China, 国家药品监督管理局, renamed to National Medical Products Administration or NMPA China in 2018) is Chinese government’s administrative body responsible for regulating pharmaceuticals, medical devices, and cosmetics in China.
Follow this link to read a 2018 China Med Device blog about the recent reform and reorganization in China’s State Council, resulted in the NMPA being created to replace CFDA.
China NMPA (follow this link to its official website in Chinese) is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR). It is responsible for creating and supervising the implementation of policies, plans and standards governing the quality and safety of drugs, cosmetics, and medical devices. NMPA also oversees standards-setting, registration, and quality management of drugs, cosmetics, and medical devices, as well as post-market inspection and risk management and registration of licensed pharmacists.
What does China NMPA/CFDA do?
Specifically, NMPA is responsible for these 10 functions to regulate drugs, medical devices, and cosmetics in the Chinese mainland market:
⦁ Responsible for the safety supervision and management of drugs (including Chinese medicine, ethnic medicine, the same below), medical equipment and cosmetics. Formulate supervision and management policy planning, organize drafting of draft laws and regulations, formulate departmental regulations, and supervise implementation. Study and develop management and service policies that encourage new technologies and products for pharmaceuticals, medical devices, and cosmetics.
⦁ Responsible for the standard management of pharmaceuticals, medical devices, and cosmetics. Organize the formulation and publication of national pharmacopeia and other pharmaceutical and medical device standards, organize the formulation of cosmetic standards, organize the development of a classification management system, and supervise the implementation. Participate in the formulation of the national essential medicines catalogs and cooperate with the implementation of the national essential medicine system.
⦁ Responsible for the registration management of pharmaceuticals, medical devices and cosmetics. Formulate a registration management system, strictly review and approve the listing review, improve the facilitation measures for review and approval, and organize implementation.
⦁ Responsible for the quality management of pharmaceuticals, medical devices, and cosmetics. Develop quality management practices and supervise implementation. Formulate production quality management regulations and implement them according to their duties. Develop management, use quality management practices and guide implementation.
⦁ Responsible for risk management of drugs, medical devices, and cosmetics after listing. Organize the monitoring, evaluation, and disposal of adverse drug reactions, medical device adverse events and cosmetic adverse reactions. To undertake the safety emergency management of drugs, medical devices, and cosmetics in accordance with the law.
⦁ Responsible for the admission management of licensed pharmacists. Formulate a system for the qualification of licensed pharmacists and guide the supervision of the registration of licensed pharmacists.
⦁ Responsible for organizing and guiding the supervision and inspection of drugs, medical devices and cosmetics. Formulate an inspection system, investigate and deal with illegal acts in the registration of drugs, medical devices and cosmetics according to law, and organize and guide the investigation and punishment of illegal activities in production links.
⦁ Responsible for foreign exchanges and cooperation in the field of supervision and management of pharmaceuticals, medical devices and cosmetics, and participate in the formulation of relevant international regulatory rules and standards.
⦁ Responsible for guiding the work of drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government.
⦁ Completing other tasks assigned by the Party Central Committee and the State Council.
How is China CFDA/NMPA organized?
Major functional NMPA departments related to overseas medical device and IVD regulatory affairs and registrations in China are:
⦁ Department of Policy, Law, and Regulation
Researches major policies, drafts laws, regulations and standards, and provides legal review of relevant regulatory documents. Responsible for publicizing related laws and standards, and overseeing the coordination of administrative and law enforcement.
⦁ Department of Medical Device Registration
Drafts and supervises the implementation of standards for medical device registration. Establishes classification, naming and coding rules; sets quality management standards and technical guidelines for clinical trials; oversees the medical device registration management system. Responsible for R&D facility inspections and investigating and punishing illegal acts.
⦁ Department of Medical Device Supervision and Administration
Drafts and supervises the implementation of quality management standards for medical device production, operation and use. Guides manufacturing facility inspections and conducts quality sampling inspections and reporting; investigates and punishes serious illegal acts; monitors ADR reporting and response.
⦁ Technology and International Cooperation (Hong Kong, Macao and Taiwan Office) Researches scientific tools and methods for the review, supervision and management of drugs, medical devices and cosmetics; manages foreign-related affairs and participates in the formulation of rules and standards for international supervision. Drafts policies and standards for the management and use of new technologies and products; laboratory construction and management; qualifications for inspection and testing institutions and inspection norms. Manages major scientific and technological projects.
⦁ China’s National Institute for Food and Drug Control
Reference: http://www.nmpa.gov.cn/WS04/CL2164/ http://www.nifdc.org.cn/nifdc/zjyjsh/zjyjshao/20190117161712.html
NMPA also owns China’s National Institute for Food and Drug Control 中国食品药品检定研究院 that is China’s statutory body and the highest-tech arbitration institution for the inspection of the quality of pharmaceutical biological products. This institute conducts the examination and approval registration and import inspection of products in the fields of medicines, biological products, medical devices, food, health foods, cosmetics, laboratory animals and packaging materials. It also provides supervision and inspection, safety evaluation and the issuance of biological products, responsible for the research, distribution, and management of national drugs, medical device reference materials and production test bacteria, and carry out related technical research work.
Where to obtain the Chinese standards and regulations in English?
There is no single site for all the Chinese standards & NMPA (CFDA) regulations, which are issued by different authorities: Chinese state council, NMPA, CMDE (Center for Medical Device Evaluation) and SAC (Standardization Administration of China). You can find the important laws and regulations on our website: https://ChinaMedDevice.com/resources/.
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How to keep up with CFDA/NMPA regulatory updates?
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Read and subscribe our CFDA/NMPA Blog;
Browse our CFDA/NMPA-related Q&As;
Download latest CFDA/NMPA regulatory documents in English;
Attend these CFDA/NMPA webinars;
Sign up for our CFDA/NMPA Newsletter on this page;
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About China Med Device
China Med Device, LLC (https://ChinaMedDevice.com) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.