OBJECTIVE To collect and analyze some policies used for expedited review of medical products in dealing with public health emergencies in China and discuss administrative proposals for medical products emergency use, which are suitable in China, for offering a reference for amending related laws and regulations in the future. METHODS Relative policies and regulation and literatures are consulted, relative policies in China and U.S were analyzed. RESULTS AND CONCLUSION In U.S. The Emergency Use Authorization had been amended time after time, which is comparatively completed. In China expedited review of medical products were valued, other than emergency use authorization, which needed to be institutionalized.
ZHONG Xuan-wei, HAN Ruo-si, LI Bo.
The Analysis and Consideration for Emergency Policies of Medical Products Used for Dealing with Public Health Emergency in China and US[J]. Chinese Pharmaceutical Journal, 2020, 55(23): 1979-1984 https://doi.org/10.11669/cpj.2020.23.013
[1] CONGRESS. Project BioShield Act of 2004(Public Law 108-276) [EB/OL]. (2004-07-21) [2020-03-19]. http: / /www. gpo. gov /fdsys /pkg /PLAW-108publ276 /pdf /PLAW-108publ276.pdf. [2] FDA. Emergency Use Authorization of Medical Products and Related Authorities [EB/OL]. (2018-10-17)[2020-03-19]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities. [3] 113th Congress. Public Law 113-5. Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. (PAHPRA). [EB/ OL]. (2013-03-13) [2020-03-19]. https://www.govinfo.gov/content/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf. [4] FDA. FOOD AND DRUGS [EB/ OL]. (1997-11-21) [2020-03-19]. https://www.govinfo.gov/content/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partE-sec360bbb-3.pdf. [5] FDA. Emergency Use Authorization of Medical Products and Related Authorities [EB/OL]. (2017-07)[2020-03-19]. https://www.fda.gov/media/97321/download. [6] CONGRESS. 21st Century Cures Act(PUBLIC LAW 114-255)[EB/OL]. (2016-12-13) [2020-03-20]. https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf. [7] FDA. FEDERAL FOOD, DRUG, AND COSMETIC ACT. (2020-03-27) [2020-03-28]. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act. [8] YAO L X, QIN J, YAN J Y, et al. Emergency use authorization of medical products[J]. Chin J New Drugs(中国新药杂志),2013,22(4): 393-401. [9] FDA. Emergency Use Authorization[EB /OL]. (2020-06-26) [2020-06-26]. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. [10] The National People's Congress of the People's Republic of China. The Law of the people's Republic of China on Vaccine administration[EB /OL]. (2019-07-02) [2020-03-10]. http: //www.nmpa.gov.cn/WS04/CL2076/338648.html. [11] YANG Y. How to estabilish the foundation of Emergency Use Authorization of Medical Products[N]. China Pharmaceutical New(中国医药报),2019-09-24(003). [12] CFDA. National Food and Drug Administration National Special approval procedures of Medical Products[EB/OL]. 2005-11-18) [2020-03-10]. https://www.nmpa.gov.cn/yaopin/ypfgwj/ypfgbmgzh/20051118010101724.html. [13] CFDA. Notice on the issuance of the procedures of emergency approval for medical products and devices [EB /OL]. (2009-08-28) [2020-03-10]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20090828120001149.html. [14] CMDE. The latest summary of emergency review and approval products[EB /OL]. (2020-06-12) [2020-06-26]. https://mp.weixin.qq.com/s/lAcSGKnPs-iOrHF2XK1Wcg. [15] PRC. The Peoples Republic of China Notice on the implementation of Emergency Regulations for Irradiation and Sterilization of Medical Disposable Protective Clothing (temporary) during the epidemic [EB/OL]. (2020-02-08) [2020-06-26]. http://www.gov.cn/xinwen/2020-02/08/content_5476127.htm. [16] LI L, JIAO H. Fully guarantee the supply and quality and safety of drugs and medical devices for epidemic prevention and control [EB /OL]. (2020-04-01) [2020-04-06]. http://www.qstheory.cn/dukan/qs/2020-04/01/c_1125791125.htm. [17] SUN Y. Consideration on drug review and approval policies related to public health emergencies[J]. Drug Eval Res(药物评价研究),2020,43(3):402-411.