http://eng.sfda.gov.cn/WS03/CL0755/

The State Food and Drug Administration (SFDA) (Chinese: 国家食品药品监督管理局) is founded on the basis of the State Drug Administration. The State Food and Drug Administration is directly under the State Council of the People’s Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China.

On July 10, 2007, Zheng Xiaoyu, the former head of China’s State Food And Drug Administration, was executed for taking bribes from various firms in exchange for state licenses related to product safety.[1]

Main responsibilities

1. To organize relevant authorities to draft laws and regulations on the safety management of food, health food and cosmetics; organize relevant authorities to formulate comprehensive supervision policy, work plan and supervise its implementation.
2. To exercise comprehensive supervision on the safety management of food, health food and cosmetics in accordance with laws; organize and coordinate supervision work on the safety of food, health food and cosmetics carried out by relevant authorities.
3. To organize and carry out investigation and impose punishment on serious safety accidents of food, health food and cosmetics; delegated by the State Council, organize, coordinate and conduct specific law-enforcement campaigns over safety of food, health food and cosmetics nationwide; organize, coordinate and collaborate with relevant authorities in carrying out emergency rescue work on serious safety accidents of food, health food and cosmetics.
4. To draft law and regulations on administration of medical devices and supervise their enforcement; take charge of registration and regulation of medical devices; draft relevant national standards, draw up and revise professional standards of medical devices, manufacturing practice and supervise their implementation.
5. To be in charge of drug registration, draw up, revise and promulgate national standard of drugs; draw up criteria for marketing authorization of health food; review and approve health food; set up classification system for prescription drugs and OTC drugs; establish and improve ADR monitoring system; be responsible for drug reevaluation, review drugs to be withdrawn and formulate a national essential medicines list.
6. To draft and revise good practices for drug research, manufacturing, distribution and use, and supervise their implementation.
7. To control the quality of drugs and medical devices in manufacturers, distributors and medical institutions; release national quality bulletin on drugs and medical devices on a regular basis; investigate and punish illegal activities of producing and selling counterfeit and inferior drugs and medical devices in accordance with law.
8. To regulate radioactive pharmaceuticals, narcotics, toxics, psycho -tropics, and other controlled drugs and devices in accordance with law.
9. To draw up and improve qualification system for licensed pharmacist, supervise and direct the registration of licensed pharmacist.
10. To direct national drug regulation and comprehensive supervision on the safety management of food, health food and cosmetics.
11. To carry out exchanges and cooperation in drug regulation, relevant safety management of food, health food and cosmetics with foreign governments and international organizations.
12. To undertake other work assigned by the State Council.

The State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies. This regulatory hole, which has resulted in considerable international news coverage unfavorable to China, has been known for a decade, but failure of Chinese regulatory agencies to cooperate has prevented effective regulation.^[2]

Commissioner

Commissioner: Mr. Li Yin

Deputy Commissioners: Mr. Zhen, Mr. Jiping Li & Mr. Zhenjia Bian

Contact

State Food and Drug Administration Address: 26 Xuanwumen Xidajie, Beijing, 100053, P.R. China Fax: 86-010-68310909

• Dali Yang, “Regulatory Learning and Its Discontents in China: Promise and Tragedy at the State Food and Drug Administration,” in John Gillespie and Randall Peerenboom, eds., Pushing Back Globalization, Routledge, 2009.

• China State Food And Drug Administration at the Open Directory Project
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

People’s Republic of China 中华人民共和国 Zhōnghuá Rénmín Gònghéguó
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