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24-543: The agency had multiple former names, including China Food and Drug Administration and State Food and Drug Administration . The National Medical Products Administration was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the former regulatory body was rebranded and restructured as the China Food and Drug Administration, elevating it to a ministerial-level agency. In 2018, as part of China's 2018 government administration overhaul,

48-504: Is a significant regulator in the area of e-commerce in China . As of at least 2024, the SAMR provincial agencies for Jiangsu, Zhejiang, and Shanghai have been particularly active in antitrust enforcement. SAMR's antitrust enforcement approach has been more stringent than pre-SAMR enforcement, and has remained more stringent as of at least early 2024. The Administration was created in

72-511: Is broken down as follows (as of October 2023): Copies of standards (written in simplified Chinese) may be obtained from the SPC web store. A non-exhaustive list of National Standards of the People's Republic of China is listed as follows, accompanied with similar international standards of ISO, marked as identical (IDT), equivalent (EQV), or non-equivalent (NEQ). Changes are made frequently within

96-575: 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 10 July 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 licences related to product safety. Draft laws, regulations and rules and policy plans on

120-528: Is now accepted. New procedures released for Medical Device Regulatory Services in Europe. https://www.freyrsolutions.com/medical-devices/medical-device-regulatory-services-in-europe State Administration for Market Regulation The State Administration for Market Regulation ( SAMR ; 国家市场监督管理总局 ) is a Chinese ministerial-level agency directly under the State Council of the People's Republic of China responsible for market supervision and management. SAMR

144-713: 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 three classes. Depending on the risk classification, different aspects are required: Internal structure of CFDA (forerunner of NMPA) The medical devices regulatory system is based on regulations issued by the State Council, NMPA orders and NMPA documents that provide detailed rules for medical device registration and licensing practice. Medical device type testing must be based upon

168-498: The China Compulsory Certificate (CCC or 3C) certification. If there is no corresponding mandatory national standard, CCC is not required. A Chinese standard code has three parts: the prefix, the sequential number, and the year number. For example, GB 2312-1980 refers to the national compulsory standard (GB), sequential number 2312, revision year 1980. Besides the national standard repository, China allows

192-820: The General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), the China Food and Drug Administration (CFDA), and the State Administration of Industry and Commerce (SAIC). In 2018, SAMR began a probe into Pinduoduo following the company being criticized extensively in domestic media for its selling of shanzhai and counterfeit products. In November 2020, SAMR issued antitrust guidelines which addressed platform economy company issues. These guidelines came into effect in February 2021. Among other provisions,

216-478: The Supreme People's Court ruled that although compulsory standards do not enjoy copyright protections, publishing houses can be given exclusive, sui generis rights to publish a compulsory standard. The Standardization Administration operates a website for obtaining digital copies of the standards (excluding those dealing with food safety, environment protection, and civil engineering). The availability

240-747: The 2018 Chinese overhaul of government administration, and merged or abolished a number of previous agencies, such as the State Intellectual Property Office . SAMR was created under the banner of the Central Comprehensively Deepening Reforms Commission under Xi Jinping , current General Secretary of the Chinese Communist Party . The Administration consolidates in one ministry the market regulation functions previously shared by three separate agencies,

264-530: 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 were released. 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 six to seven years down to two or three years and data from overseas clinical trials

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288-497: 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 NMPA

312-519: The Standardization Law, national standards are divided into mandatory national standards and recommended national standards. Mandatory national standards are prefixed "GB". Recommended national standards are prefixed " GB/T ". Guidance technical documents are prefixed with "GB/Z", but are not legally part of the national standard system. Mandatory national standards are the basis for the product testing which products must undergo during

336-494: 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

360-473: 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

384-456: The guidelines state that variable interest entity structures will no longer be exempt from merger review and that SAMR may investigate acquisitions of emerging platforms even when the parties turnover does not meet notification thresholds. In March 2021, Xi Jinping stated that China would strengthen anti-trust enforcement to ensure healthy healthy and sustainable development of the platform economy. In November 2021, SAMR's antitrust bureau

408-483: 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

432-697: The name was changed to 'National Medical Products Administration' and merged into the newly created State Administration for Market Regulation . The headquarters are in Xicheng , Beijing . In its first incarnation as the CFDA, the NMPA 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. The National Medical Products Administration

456-409: 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

480-511: The registration of standards by industry/trade, by localities (DB, Dìfāng Biāozhǔn, "local standard"), by associations (T), or by an individual company (Q). The overall prefix number-year format is retained. Under the first clause of Article 5 of the Copyright Law of the People's Republic of China , compulsory standards are not copyrightable as they fall under "other documents of a legislative, administrative or judicial nature". In 1999,

504-485: 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

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528-871: 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

552-554: Was established in 2018. It is China's primary antitrust regulator. SAMR is China's primary antitrust regulator, although its authority also has some overlap with the National Development and Reform Commission and the Ministry of Industry and Information Technology . It also has regulatory functions involving data regulation and labor issues. The E-Commerce Law is part of SAMR's broader mandate, and therefore it

576-515: Was upgraded to vice ministerial status following the appointment of Gan Lin as the bureau's new chief. Guobiao The National Standards of the People's Republic of China ( 中华人民共和国国家标准 ), coded as GB , are the standards issued by the Standardization Administration of China under the authorization of Article 10 of the Standardization Law of the People's Republic of China. According to Article 2 of

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