China Food and Drug Administration

China Food and Drug Administration
国家食品药品监督管理总局

Formation	1950 (predecessor organization) 2013 (latest re-organization)
Type	Ministry-level regulatory body
Headquarters	26-Yuan, Xuanwumen Avenue West, Xicheng District, Beijing
Location	Beijing, China
Director	Bi Jingquan
Deputy Directors	Yin Li, Wang Mingzhu, Teng Jiacai, Wu Zhen, Jiao Hong
Discipline Inspection Leader	Li Wusi
Parent organization	State Council of the People's Republic of China
Affiliations	Commission on Food Safety
Website	www.sda.gov.cn

The China Food and Drug Administration (CFDA)^[1] (Chinese: 国家食品药品监督管理总局) was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the regulatory body was rebranded and restructured as the China Food and Drug Administration, elevating it to a ministerial-level agency.^[2] The CFDA replaced a large group of overlapping regulators with an entity similar to the Food and Drug Administration of the United States, streamlining regulation processes for food and drug safety.^[3] The China 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.^[4]

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.^[5]

Main responsibilities

Draft laws, regulations and rules and policy plans on the administration and supervision of food (including food additives and health food, the same below) safety, drugs (including traditional Chinese medicines and ethno-medicines, the same below), medical devices and cosmetics; formulate normative documents, and facilitate the establishment and implementation of the food safety responsibility mechanism, under which food companies shall bear the main responsibility and local people's governments shall take integrated responsibility; establish the direct reporting system for critical food and drug information and supervise its implementation; take measures to reduce risks on regional and systemic food and drug safety;

Formulate the regulations on food administrative licensing and supervise their implementation; establish food safety risk management mechanism, formulate annual plans for nationwide inspection for food safety and programs for major control actions, and organize their implementation; establish the unified food safety information release system and release information on important food safety issues; participate in formulating food safety risk monitoring plans and food safety standards, and undertake food safety risk monitoring thereon;

Organize the formulation and publication of the national pharmacopeia, other drug and medical device standards and classification system, and supervise their implementation; develop good practices on research, production, distribution and use of drugs and medical devices, and supervise their implementation; undertake drug and medical device registration, supervision and inspection; establish monitoring system for adverse drug reactions, adverse events of medical devices, and undertake monitoring and response activities; draw up and improve regulations and qualifications for licensed pharmacists, guide and supervise the registration work; participate in formulating national essential medicine list and assist its implementation; formulate administrative provisions for cosmetics administration and supervise their implementation;

Formulate the investigation and enforcement system for food, drugs, medical devices and cosmetics, and organize their implementation; organize the investigation and punishment on major violations; establish recall and disposal system for defect products, and supervise the implementation;

Establish food and drug emergency response system, organize and guide the emergency response and investigation on food and drug safety incident, and supervise the implementation of investigation and punishment;

Formulate science and technology development plans for food and drug safety, and organize their implementation; accelerate the construction of food and drug testing system, electronic supervision tracking system, and information system;

Undertake the public communication, education and training, and international exchanges and cooperation in the field of food and drug safety; promote the establishment of credibility system;

Guide food and drug administration works of local governments, regulate administrative activities, and improve the interlocking mechanism between administrative enforcement and criminal justice;

Undertake the routine work of the Food Safety Commission of the State Council; take charge of comprehensive coordination on food safety administration, facilitate and improve the cooperation and coordination mechanism; supervise the work of provincial people's governments on food safety administration, and evaluate their performance;

Undertake other work assigned by the State Council and the Food Safety Commission of 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.^[6]

CFDA registration for medical devices

The CFDA is responsible for registration of medical devices for the Chinese market. All medical devices have to be classified by the CFDA according to its risk in 3 classes. Depending on the risk classification, different aspects are required:

• For medical devices of class I: product tests are sometimes required
• For medical devices of class II: product tests are always required and clinical trials are sometimes required
• For medical devices of class III: product tests are always required and clinical trials are always required

Structure and organization of CFDA

Internal structure of CFDA^[7]

1. General Office
2. Dept. of Legal Affairs
3. Dept. of Food Safety Supervision (I - III)
4. Dept of Drug and Cosmetics Registration (Dept. of TCMs and Ethno-Medicines Supervision)
5. Dept. of Medical Device Registration
6. Dept. of Drug Cosmetics Supervision
7. Dept. of Medical Device Supervision
8. Bureau of Investigation and Enforcement
9. Dept. of Emergency Management
10. Dept. of Science, Technology and Standards
11. Dept. of Media and Publicity
12. Dept. of Human Resources
13. Dept. of Planning and Finance
14. Dept. of International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs)

Director

Director: Mr. Bi Jingquan (since January 2015)

Other leaders:

• Mr. Yin Li (Deputy Director)
• Ms. Wang Mingzhu (Deputy Director)
• Mr. Teng Jiacai (Deputy Director)
• Mr. Wu Zhen (Deputy Director)
• Ms. Jiao Hong (Deputy Director)
• Mr. Li Wusi (Head of discipline inspection group)
• Mr. Sun Xianze (Assistant Director for Drug Safety )
• Mr. Guo Wenqi (Assistant Director for Food Safety)

Standards and Regulations

The medical devices regulatory system is based on regulations issued by the State Council, CFDA orders and CFDA documents that provide detailed rules for medical device registration and licensing practice. ^[8]Medical device type testing must be based upon the Chinese National Standard (Chinese: Guobiao, GB) or at least on an Industry Standard (YY). Thy system is undergoing frequent changes and adjustments. In October 2013, more than 104 new YY Standards have been released.

See also

• AQSIQ
• Pharmaceutical industry in China
• Food Administration
• Food safety in China
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• United States Food and Drug Administration

References

Further reading

• 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.

External links

Health in China Healthcare Health Disease surveillance Healthcare system reform Women's health Health informatics Tobacco Control Association Barefoot doctor Patriotic Health Campaign China Welfare Institute Hospitals in China Medical schools Organ transplantation Medicine and pharmaceutical Medicine Traditional Chinese medicine Pharmacy Pharmaceutical industry Biotechnology Diseases Avian influenza Blue-ear disease Cardiovascular disease Chronic diseases Enterovirus 71 (EV71) Fujian flu Hepatitis B HIV/AIDS Iodine deficiency lead poisoning scandal Leprosy Mental health Obesity Pneumonic plague SARS (outbreak progress) Stroke Swine influenza outbreak Tuberculosis Disease-related deaths Government Ministry of Health Chinese Center for Disease Control and Prevention State Food and Drug Administration State Administration of Traditional Chinese Medicine State Administration of Work Safety Hong Kong Department of Health * Macau Secretariat for Social Affairs and Culture * National Population and Family Planning Commission General Administration of Quality Supervision, Inspection and Quarantine Other related issues Demographics Dust storms Environment Food safety Illegal drug trade Pollution Poverty Prostitution Smoking Vegetarianism Violence against doctors in China Yi Nao Water supply and sanitation Studies China-Cornell-Oxford Project (The China Study) China Health and Nutrition Survey Chinese Family Panel Studies Chinese Health and Retirement Survey  * Of special administrative regions

State Council of the People's Republic of China Incumbent (12th): Li Keqiang Government State Council (Cabinet) (Plenary meeting) members Executive meeting Premier Vice Premiers State Councillors Secretary-General Ministers of Ministries and Commissions Auditor-General General Office Secretary-General Deputy Secretary-General Cabinet-level departments constituting the State Council Agriculture Audit Civil Affairs Commerce Culture Development and Reform Education Environmental Protection Ethnic Affairs Finance Foreign Affairs Health and Family Planning Housing and Urban-Rural Development Human Resources and Social Security Industry and Information Technology Justice Land and Resources National Defense People's Bank Public Security Science and Technology State Security Supervision Transport Water Resources Special organization State-owned Assets Supervision and Administration Commission Organizations China National Tourism Administration Counselor's Office of the State Council General Administration of Customs State Administration of Press, Publication, Radio, Film and Television General Administration of Quality Supervision, Inspection and Quarantine State Administration of Government Offices National Bureau of Corruption Prevention National Bureau of Statistics State Administration for Industry and Commerce State Administration for Religious Affairs State Administration of Taxation State Administration of Work Safety State Forestry Administration State General Administration of Sports State Intellectual Property Office Administrative offices Hong Kong and Macau Affairs Information/Internet Legislative Affairs Overseas Chinese Affairs Research Taiwan Affairs Association for Relations Across the Taiwan Straits Anti-cult Institutions Academy of Engineering Academy of Sciences Academy of Social Sciences Banking Regulatory Commission Development Research Center Earthquake Administration Insurance Regulatory Commission Meteorological Administration National Council for Social Security Fund National Natural Science Foundation National School of Administration Securities Regulatory Commission State Archives Administration State Electricity Regulatory Commission Xinhua News Agency State administrations/bureaus administrated by Cabinet-level agencies Atomic Energy Authority Civil Aviation Administration National Administration for the Protection of State Secrets National Energy Administration National Nuclear Safety Administration National Space Administration State Administration for Science, Technology and Industry for National Defence State Administration of Coal Mine Safety State Administration of Cultural Heritage State Administration of Foreign Exchange State Administration of Foreign Experts Affairs State Administration of Grain State Administration of Traditional Chinese Medicine State Bureau for Letters and Calls State Bureau of Civil Servants State Bureau of Surveying and Mapping State Cryptography Administration State Food and Drug Administration State Language Commission State Oceanic Administration China Coast Guard State Post Bureau China Post State Tobacco Monopoly Administration China National Tobacco Corporation Special Commissions and Steering Committees State Commission for Public Sector Reform Commission Office Commission on Food Safety National Energy Commission National Defense Mobilization Commission Leading Group for Coordinating the South-North Water Transfer Project Leading Group for Coordinating the Three Gorges Dam Project Leading Group for the Transformation of the State Council Other agencies Liaison Office in Hong Kong SAR Liaison Office in Macau SAR People's Armed Police State Council is one in the same as the Central People's Government (constitutionally since 1954)