State Food and Drug Administration of China
Encyclopedia
The State Food and Drug Administration (SFDA) 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.
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.
State Council of the People's Republic of China
The State Council of the People's Republic of China , which is largely synonymous with the Central People's Government after 1954, is the chief administrative authority of the People's Republic of China. It is chaired by the Premier and includes the heads of each governmental department and agency...
, 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
Mainland China
Mainland China, the Chinese mainland or simply the mainland, is a geopolitical term that refers to the area under the jurisdiction of the People's Republic of China . According to the Taipei-based Mainland Affairs Council, the term excludes the PRC Special Administrative Regions of Hong Kong and...
.
On July 10, 2007, Zheng Xiaoyu
Zheng Xiaoyu
Zheng Xiaoyu was director of the State Food and Drug Administration of the People's Republic of China. He was sentenced to death in the first instance trial at Beijing No.1 Intermediate Court on May 29, 2007...
, 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.
Main responsibilities
- To organize relevant authorities to draft laws and regulations on the safety management of food, health foodHealth foodThe term health food is generally used to describe foods that are considered to be beneficial to health, beyond a normal healthy diet required for human nutrition. However, the term is not precisely defined by national regulatory agencies such as the U.S...
and cosmeticsCosmeticsCosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...
; organize relevant authorities to formulate comprehensive supervision policy, work plan and supervise its implementation. - 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 cosmeticsCosmeticsCosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...
carried out by relevant authorities. - 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 foodFoodFood is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...
, healthHealthHealth is the level of functional or metabolic efficiency of a living being. In humans, it is the general condition of a person's mind, body and spirit, usually meaning to be free from illness, injury or pain...
food and cosmetics. - 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.
- 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.
- To draft and revise good practices for drug research, manufacturing, distribution and use, and supervise their implementation.
- 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.
- To regulate radioactive pharmaceuticals, narcotics, toxics, psycho -tropics, and other controlled drugs and devices in accordance with law.
- To draw up and improve qualification system for licensed pharmacist, supervise and direct the registration of licensed pharmacist.
- To direct national drug regulation and comprehensive supervision on the safety management of food, health food and cosmetics.
- To carry out exchanges and cooperation in drug regulation, relevant safety management of food, health food and cosmetics with foreign governments and international organizations.
- 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.
See also
- AQSIQ
- Pharmaceutical industry in China
- Food AdministrationFood AdministrationFood Administration may refer to various past and present organizations with responsibilities related to food in numerous countries and international organizations:- Argentina :...
- Food safety in the People's Republic of ChinaFood safety in the People's Republic of ChinaFood safety in the People's Republic of China is a growing concern relating to agriculture. China's principal crops are rice, corn, wheat, soybeans, and cotton in addition to apples and other fruits and vegetables. China's principal livestock products include pork, beef, dairy, and eggs...
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- United States Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...