National Medical Products Administration

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The National Medical Products Administration ( NMPA ), Chinese  国家 药品 监督 管理局 , formerly China Food and Drug Administration (CFDA), is a Chinese administrative authority that is responsible for the regulation (registration and monitoring) of drugs , medical devices and cosmetics for the chinese market.

history

The NMPA was founded in March 2018 as a subordinate authority to the newly created State Administration for Market Regulation (SAMR). With the creation of the SAMR, the competencies of the former authorities China Food and Drug Administration (CFDA), General Administration of Quality Supervision, Inspection and Quarantine (SAIC) and the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) were combined. The former CFDA parent Ministry of Health (MoH) was in the National Health Commission ( National Health Commission restructured).

Previously, after a reorganization, the CFDA had replaced the China State Food and Drug Administration (SFDA) in March 2013 , which in turn emerged from the reorganization of the State Drug Administration (SDA) in 2003 . The reorganizations in 2003 and 2013 had become necessary because the authority repeatedly fell into disrepute due to the acceptance of bribes and cases of corruption , and drug safety in China could no longer be fully guaranteed. In connection with this, the then head of the agency, Zheng Xiaoyu , was sentenced to death on July 10, 2007 for corruption.

Regulations

The regulations concerning the registration and certification of medical products and equipment for the Chinese market based on the guidelines of the State Council (State Council) as well as the rules and regulations of the authority itself. In addition, the required product tests if necessary on the basis of the national Chinese standards must ( chin .: Guobiao , GB) or correspond to an industry standard (YY). Medical devices and other medical products are subject to certification. The product catalogs and category lists can be viewed online, but are very unspecific and in some cases only available in Chinese. Some of the forms required for submitting an application are also not provided in English. In addition, some products are also subject to CCC certification . For some product groups, however, this requirement was revised in May 2013.

With the restructuring to the NMPA in 2018, little has changed from the perspective of foreign companies wishing to work with Chinese CROs . What is new is that the application process for medical device certification can be carried out entirely in electronic form.

New regulations, such as the new "Revised Drug Administration Law" or the new "Vaccines Administration Law", which came into force on December 1, 2019, are intended to increase trust in the domestic pharmaceutical market and help prevent violations of the law through greater personal liability on the part of employees .

New regulations have also been issued for the approval of "non-special" cosmetics.

The process of classification and certification of medical devices at the NMPA is based, as in the EU directives, on the classification of the product in one of three risk classes. Like the respective criteria, it is based on Directive 93/42 / EEC on medical devices .

Web links

Individual evidence

  1. ↑ C. Abele: China bundles and strengthens market surveillance. New "super authority" created for market surveillance - entrepreneurial responsibility increases. May 15, 2018, accessed on May 25, 2020 (www.gtai.de).
  2. ↑ China's SFDA Becomes CFDA amidst Consolidation of Power and New Leadership. (No longer available online.) In: RF Regulatory Focus. March 25, 2013, archived from the original on October 22, 2013 ; accessed on October 15, 2013 .
  3. ^ Former head of China's drug watchdog executed. (No longer available online.) In: Xinhua News Agency. October 7, 2007, archived from the original on October 9, 2012 ; accessed on October 15, 2013 .
  4. ↑ China food safety head executed. In: BBC News . July 10, 2007, accessed October 15, 2013 .
  5. ↑ China - Conversion from CCC certification to SFDA in medical technology. (No longer available online.) In: IHK Pfalz. May 15, 2013, archived from the original on October 16, 2013 ; accessed on October 15, 2013 (German).
  6. ↑ 中国 国家 认证 可 监督 管理 委员会 公告 ( Memento from August 15, 2014 in the Internet Archive ) In: CNCA China . May 2, 2013 (Chinese)
  7. ↑ What's in a name? How the CFDA became the NMPA. February 7, 2020, accessed May 25, 2020 (www.clinicalservicecenter.com).
  8. ↑ S. Schmitt: Sector compact: China's pharmaceutical sector continues to grow dynamically. Simplified access conditions for foreign companies. January 15, 2020, accessed on May 25, 2020 (www.gtai.de).
  9. ^ IHK Osnabrück - Emsland - Grafschaft Bentheim: News about certification in China. December 20, 2018, accessed on May 25, 2020 (www.osnabrueck.ihk24.de).