我国化学药品申报资料中关于生产线相关要求的审评考虑

doi:10.11669/cpj.2020.03.014

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摘要目的药品的生产场所是为满足药品生产要求的一系列生产要素的组合,其既是药品生产的硬件条件,也是注册申报时审评的物质基础。笔者旨在初步探讨我国化学药品申报资料中生产线的内涵、外延,以期为规范药品注册申报提供一定的参考。方法在梳理我国化学药品申报资料中关于生产场所信息的历次要求的基础上,结合日常药学审评工作以及具体案例进行分析。结果与结论 应明确申报资料中拟定生产线的内涵及边界,强化不同监管部门之间的有效沟通,及时更新相关证明性信息,同时还应持续关注我国关于生产线相关变更的法律法规修订进展。

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	龚青
	田洁

关键词 ：化学药品, 生产线, 相关要求, 药品审评

Abstract：OBJECTIVE The manufacturing site of drugs is a combination of a series of production factors to meet the requirements of drugs production, which is not only the material basis of drugs production, but also the evaluation basis for the review when applying for registration. The purpose of this paper is to preliminarily discuss the definition and extension of production lines for chemical drugs in China, and provide some references for standardizing new drug application. METHODS The historical requirements for manufacturing site information in application materials of chemical drugs in China were briefly introduced, with daily pharmaceutical evaluation works and specific cases study. RESULTS AND CONCLUSION It should make clear the definition and extension of production lines in the application materials, strengthen the effective communication between different regulatory authorities, update the relevant information in time, and should pay continuing attention to the revision progress of the laws and regulations requirements on the production line in China.

Key words： chemical drug production line requirement drug assessment

收稿日期: 2019-06-30

PACS:

R917

作者简介: :龚青,男,高级工程师研究方向:药品技术审评工作 Tel:(010)85242662 E-mail:gongq@cde.org.cn

引用本文:

龚青, 田洁. 我国化学药品申报资料中关于生产线相关要求的审评考虑[J]. 中国药学杂志, 2020, 55(3): 239-244. GONG Qing, TIAN Jie. Reflections on the Requirements for Production Lines in Application of Chemical Drugs in China. Chinese Pharmaceutical Journal, 2020, 55(3): 239-244.

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http://journal11.magtechjournal.com/Jwk_zgyxzz/CN/10.11669/cpj.2020.03.014 或 http://journal11.magtechjournal.com/Jwk_zgyxzz/CN/Y2020/V55/I3/239

[1]	General Office of the State Council. State Council General Office's opinion on quality and efficacy consistency evaluation of generic drug(NO.8
	[2016])[EB/OL]. 2016-2-6 [2018-11-28]. http://www.gov.cn/zhengce/content/2016-03/05/content_5049364.htm.
[2]	China Food and Drug Administration(CFDA). CFDA on evaluation of the quality and efficacy consistency of generic drugs(NO.100
	[2017])[EB/OL]. 2017-8-25 [2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0087/176734.html.
[3]	China Food and Drug Administration(CFDA). Regulations on Administration of Pharmaceutical Registration(NO.28)[EB/OL]. 2007-7-10[2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0053/24529.html.
[4]	State Food and Drug Administration(SFDA). Preparation of the registration for chemical drugs in the CTD format(NO.378
	[2010])[EB/OL]. 2010-9-25[2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0844/54391.html.
[5]	Center for Drug Eraluation(CFDA). Notice on the Information Sheet for the production process of new chemical drugs[EB/OL]. 2015-8-3[2018-11-28]. http://www.cde.org.cn/news.do?method=largeInfo&id=313461.
[6]	China Food and Drug Administration(CFDA). Trial requirements for new registration of chemical drugs(NO.80
	[2016])[EB/OL]. 2016-5-4[2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0087/151985.html.
[7]	HUANG X L. Brief introduction to the new requirements for chemical generic drugs[J]. Chin J New Drugs,2016,25(18):2103-2108.
[8]	China Food and Drug Administration(CFDA). Drug Administration Law of the People's Republic of China[EB/OL]. 2017-6-27[2018-11-28]. http://www.npc.gov.cn/npc/zfjc/zfjcelys/2017-06/27/content_2024479.html.
[9]	China Food and Drug Administration(CFDA). Regulations for the implementation of the Drug Administration Law of the People's Republic of China[EB/OL]. 2016-6-1[2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0784/171346.html.
[10]	China Food and Drug Administration(CFDA). The General Office of CFDA opinions on Regulations on Administration of Pharmaceutical Registration (revised manuscript)[EB/OL]. 2017-10-23[2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0778/178900.html.
[11]	Official of the State Council. Good Manufacturing Practice (2010 Revision)(NO.79)[EB/OL]. 2011-1-17 [2018-11-28]. http://www.gov.cn/gongbao/content/2011/content_1907093.htm.
[12]	China Food and Drug Administration(CFDA). Issuance for the certification of drugs Good Manufacturing Practice(NO.365
	[2011])[EB/OL]. 2011-8-2[2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0844/64569.html.
[13]	US. Food and Drug Administration. Current Good Manufacturing Practice(CGMP)Regulations[EB/OL]. 2018-1-11 [2018-11-28]. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm.
[14]	European Medicines Agency. EudraLex-Volume 4-Good Manufacturing Practice(GMP)guidelines[EB/OL]. 2018-2-27 [2018-11-28]. https://ec.europa.eu/health/documents/eudralex/vol-4_en.
[15]	International Soceity for Pharmaceutical Enineering. Baseline Guide Vol 3:Sterile Product Manufacturing Facilities 3rd Edition[EB/OL]. 2018-4 [2018-11-28]. https://ispe.org/publications/guidance-documents/sterile-product-manufacturing-facilities-third-edition.
[16]	US. Food and Drug Administration. Orange Book:Approved Drug Products with Therapeutic Equivalence Evaluations[DB/OL]. [2018-11-28]. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm.
[17]	China Food and Drug Administration(CFDA). CFDA on advancing drug Marketing Authorization Holder Mechanism(NO.68
	[2017])[EB/OL]. 2017-8-21 [2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0844/176274.html.
[18]	The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management(ICH Q12)[EB/OL]. 2017-11-16 [2018-11-28]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Draft_Guideline_Step2_2017_1116.pdf.
[19]	State Food and Drug Administration(SFDA). Technical guidelines for the changes in listing chemicals(NO.242
	[2008])[EB/OL]. 2008-5-15[2018-11-28]. http://www.nmpa.gov.cn/WS04/CL2196/323682.html.
[20]	China Food and Drug Administration(CFDA). Technical guidelines for the changes of production process in listing chemicals(NO.140
	[2017])[EB/OL]. 2017-8-29[2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0087/176829.html.
[21]	China Food and Drug Administration(CFDA). The General Office of CFDA on Simplified regulations on changes in drug production sites(Draft for comments)and Technical guidelines for the study of site change(Draft for comments)[EB/OL]. 2017-10-17 [2018-11-28]. http://samr.cfda.gov.cn/WS01/CL0778/178605.html.