China Food and Drug Administration

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China Food and Drug Administration
国家食品药品监督管理总局
China Food and Drug Administration Badge.PNG
Formation1950 (predecessor organization)
2013 (latest re-organization)
TypeMinistry-level regulatory body
Headquarters26-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 eng.cfda.gov.cn
Food & Drug Administration enforcement badge of China CFDA(China Food and Drug Administration) badge.svg
Food & Drug Administration enforcement badge of China

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 headquarters are in Xicheng District, Beijing. [3]

Simplified Chinese characters standardized Chinese characters developed in mainland China

Simplified Chinese characters are standardized Chinese characters prescribed in the Table of General Standard Chinese Characters for use in mainland China. Along with traditional Chinese characters, they are one of the two standard character sets of the contemporary Chinese written language. The government of the People's Republic of China in mainland China has promoted them for use in printing since the 1950s and 1960s to encourage literacy. They are officially used in the People's Republic of China and Singapore.

Xicheng District District in Beijing, Peoples Republic of China

Xicheng District is a district of Beijing. Xicheng District spans 32 square kilometres (12 sq mi), making it the largest portion of the old city, and has 706,691 inhabitants. Its postal code is 100032. Xicheng is subdivided into 15 subdistricts of the city proper of Beijing. The former Xuanwu District was merged into Xicheng on July 2010.

Beijing Municipality in Peoples Republic of China

Beijing, formerly romanized as Peking, is the capital of the People's Republic of China, the world's third most populous city proper, and most populous capital city. The city, located in northern China, is governed as a municipality under the direct administration of central government with 16 urban, suburban, and rural districts. Beijing Municipality is surrounded by Hebei Province with the exception of neighboring Tianjin Municipality to the southeast; together the three divisions form the Jingjinji metropolitan region and the national capital region of China.

Contents

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. [4] 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. [5]

Food and Drug Administration agency of the United States Department of Health and Human Services

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget is paid by people who consume pharmaceutical products, due to the Prescription Drug User Fee Act.

State Council of the Peoples Republic of China chief administrative authority of the Peoples Republic of China

The State Council, constitutionally synonymous with the Central People's Government since 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 of the cabinet-level executive departments. Currently, the council has 35 members: the premier, one executive vice premier, three other vice premiers, five state councilors, and 25 additional ministers and chairs of major agencies. In the politics of the People's Republic of China, the Central People's Government forms one of three interlocking branches of power, the others being the Communist Party of China and the People's Liberation Army. The State Council directly oversees the various subordinate People's Governments in the provinces, and in practice maintains membership with the top levels of the Communist Party of China.

Mainland China geopolitical area under the jurisdiction of the Peoples Republic of China excluding Special Administrative Regions

Mainland China, also known as the Chinese mainland, is the geopolitical as well as geographical area under the direct jurisdiction of the People's Republic of China (PRC). It includes Hainan island and strictly speaking, politically, does not include the special administrative regions of Hong Kong and Macau, even though both are partially on the geographic mainland.

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. [6]

Zheng Xiaoyu Chinese official executed for corruption

Zheng Xiaoyu was the director of the State Food and Drug Administration of the People's Republic of China from 2003 to 2005. He was sentenced to death for corruption and allowing possibly tainted products in Mainland China in the first instance trial at Beijing No.1 Intermediate Court on May 29, 2007. He was executed on July 10, 2007.

As part of China's 2018 government administration overhaul, the CFDA was merged into the newly-created State Administration for Market Regulation.

State Administration for Market Regulation organization of the Peoples Republic of China

The State Administration for Market Regulation (SAMR) is the People's Republic of China's governmental authority for regulating areas such as market competition, monopolies, intellectual property, and drug safety. The Administration was created in the 2018 Chinese overhaul of government administration, and merged or abolished a number of previous agencies, such as the State Intellectual Property Office.

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. [7]

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:

Organizational structure

Internal structure of CFDA [8]

  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)

Principal officials

Director: Mr. Bi Jingquan (since January 2015)

Other leaders:

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. [9] Medical device type testing must be based upon the Chinese National Standard (Chinese: Guobiao, GB) or at least on an Industry Standard (YY). The system is undergoing frequent changes and adjustments. In October 2013, more than 104 new YY Standards have been released.

Performance

Only 100 new drugs were approved between 2001 and 2016, about a third of the number in most Western countries. Approval times have been cut from 6 to 7 years down to 2 or 3 and data from foreign clinical trials is now accepted. [10]

See also

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Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).

Federal Food, Drug, and Cosmetic Act

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Medical device Any instrument, apparatus, implant, in vitro reagent, or similar or related article used for diagnostic and/or therapeutic purposes

A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

The International Nomenclature of Cosmetic Ingredients, abbreviated INCI, is a system of names for waxes, oils, pigments, chemicals, and other ingredients of soaps, cosmetics, and the like, based on scientific names and other Latin and English words. INCI names often differ greatly from systematic chemical nomenclature or from more common trivial names.

Food and Drug Administration, Maharashtra State, is Maharashtra's primary instrument of consumer protection. It is a law enforcement agency. In 1970, the Government of Maharashtra entrusted the responsibility of enforcement of the Prevention of Food Adulteration Act, 1954 to FDA which is when it got its present name. The regulations are implemented by the following independent section :- (A) Drug Section (B) Food Section (C) Food and Drug Control Laboratories (A) Drugs Section :–

The Food and Drugs Act is an act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics. It was first passed in 1920 and most recently revised in 1985. It attempts to ensure that these products are safe, that their ingredients are disclosed and that drugs are effective and are not sold as food or cosmetics. It also states that cures for disease listed in Schedule A, cannot be advertised to the general public.

A food safety agency or food administration is a kind of agency found in various countries and international organizations with responsibilities related to food, primarily with ensuring the safety of food sold or distributed to the population, and with ensuring that food sellers inform the population of the origins and health qualities and risks associated with food being sold.

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Food safety in China

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The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.

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The following outline is provided as an overview of and topical guide to clinical research:

Food and Drug Administration Modernization Act of 1997

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Food and Drug Administration Safety and Innovation Act

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Medical Device Regulation Act

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References

  1. ↑ http://eng.sfda.gov.cn/WS03/CL0755/
  2. ↑ "China gets stronger food, drug regulator." China Daily, Xinhua. 22 March 2013. http://www.chinadaily.com.cn/business/2013-03/22/content_16336113.htm
  3. ↑ "Contact CFDA." China Food and Drug Administration. Retrieved on August 18, 2016. "Address: 26 Xuanwumen Xidajie, Beijing, 100053, P.R. China" Chinese address: "地址：北京市西城区宣武门西大街26号院2号楼"
  4. ↑ "China to elevate food, drug agency to general administration." 10 March 2013. Xinhua. http://news.xinhuanet.com/english/china/2013-03/10/c_132221729.htm
  5. ↑ "Consolidation of the China Food and Drug Administration," by Nick Beckett and David Pountney. CMS Cameron McKenna. 3 June 2013. http://www.lexology.com/library/detail.aspx?g=20a4e134-7414-4f4d-88d5-d7dd36d800a7
  6. ↑ China food safety head executed
  7. ↑ "Chinese Chemicals Flow Unchecked to World Drug Market" article reported by Walt Bogdanich, Jake Hooker and Andrew W. Lehren and written by Mr. Bogdanich in The New York Times October 31, 2007
  8. ↑ "CFDA organizational structure" . Retrieved 2014-12-29.
  9. ↑ "CFDA: An Update on the Regulatory Process in China". European Medical Device Technology. Retrieved 2015-06-16.
  10. ↑ "In China, Desperate Patients Smuggle Drugs. Or Make Their Own". New York Times. 11 November 2018. Retrieved 22 December 2018.

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