国内外药品出口销售证明发放制度比较研究
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摘要
目的:比较相关国家药品出口销售证明发放制度的异同,为完善我国药品出口销售证明发放制度提供参考。方法:调研美国食品药品监督局、加拿大卫生部、澳大利亚医疗用品管理局、英国药品健康产品管理局和印度中央药物控制组织,比较各国药品出口销售证明(简称CPP)发放制度在认证范围、申请资料、申请流程等方面的异同点。结果与结论:我国药品出口销售证明发放制度主要存在4个方面的不足之处:缺乏正式生效的药品出口销售证明发放指南;认证范围仅局限于中国已上市的产品;缺乏对符合GMP规范生产但未在国内上市的产品认证;未对申请药品出口销售证明的产品建立GMP场地检查制度。建议我国食品药品监督管理部门加快落实并生效《药品出口销售证明管理规定》,扩大药品出口销售证明的认证范围,建立药品出口销售证明发放的现场检查机制。
Objective: To compare differences and similarities of the issuing systems of certificate for pharmaceutical products export(CPP) among relevant countries and to provide references for improving the issuing system of CPP of China. Methods: The issuing systems of CPP of US Food and Drug Administration(FDA), Health Canada, Australian Therapeutic Goods Administration, Medicines and Healthcare Products Regulatory Agency of UK and Indian's Central Drugs Standard Control Organization were studied. The differences and similarities of the issuing systems in certification scopes, application documents and application procedure were compared. Results and Conclusion: China's issuing system of CPP has four defects: lack of formal and effective CPP issuing guidelines; limited certification scope only applied to approved products; lack of certification for products which were approved by GMP, yet not sold in China; lack of on-site inspection system for the products which have applied for CPP. It was suggested that National Medical Products Administration should expedite the implementation of Regulation for Management of CPP, the certification scope of CPP should be expanded and the on-site inspection mechanism of products which have applied for CPP should be established.
Objective: To compare differences and similarities of the issuing systems of certificate for pharmaceutical products export(CPP) among relevant countries and to provide references for improving the issuing system of CPP of China. Methods: The issuing systems of CPP of US Food and Drug Administration(FDA), Health Canada, Australian Therapeutic Goods Administration, Medicines and Healthcare Products Regulatory Agency of UK and Indian's Central Drugs Standard Control Organization were studied. The differences and similarities of the issuing systems in certification scopes, application documents and application procedure were compared. Results and Conclusion: China's issuing system of CPP has four defects: lack of formal and effective CPP issuing guidelines; limited certification scope only applied to approved products; lack of certification for products which were approved by GMP, yet not sold in China; lack of on-site inspection system for the products which have applied for CPP. It was suggested that National Medical Products Administration should expedite the implementation of Regulation for Management of CPP, the certification scope of CPP should be expanded and the on-site inspection mechanism of products which have applied for CPP should be established.
引文
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[16]裘敏杰,范月萍,董耿,等.医疗器械产品出口销售证明用途及管理建议[J].现代商贸工业,2016,37(10):43-44.
[17]珠海市食品药品监督管理局.药品证明书(CPP)核发[EB/OL].(2014-08-26)[2017-07-06].http://www.gdda.gov.cn/sofpro/cms/previewjspfile/fdazh/cms_0000000000000000434_tpl.jsp?requestCode=284612&CategoryID=1834.
[18]国家食品药品监督管理局.关于印发药品加工出口管理规定(试行)的通知[EB/OL].(2003-07-29)[2017-07-06]. http://www.sda.gov.cn/WS01/CL0058/9342.html.
[19]国家食品药品监督管理总局.关于出口欧盟原料药证明文件有关事项的通知[EB/OL].(2013-05-07)[2017-07-06]. http://www.sda.gov.cn/WS01/CL0844/80444.html.
[2]WHO. WHO Certification Scheme on the Quality of PharmaceuticalProductsMovinginInternational Commerce:Questions and Answers(Q&A)[EB/OL].(2010-05)[2017-05-10].http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/qas_certif_scheme_2012.pdf?ua=1, 2010-05.
[3]冷鹏,孙大卫.部分国家的COPP概述[J].中国药事,2008,22(6):522-523.
[4]WHO. Guidelines on the Implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce[EB/OL].(2015-11-24)[2017-05-10].http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/guidelines/en/.
[5]WHO. Model Certificate of a Pharmaceutical Product[EB/OL].[2017-07-06]. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/en/.
[6]Imports Exports Compliance Branch of US Food and Drug Administration. Certificate of a Pharmaceutical Product(CPP)Application[EB/OL].[2017-07-06]. https://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm441206.pdf.
[7]Imports and Exports Compliance of US Food and Drug Administration. General Certificates of Pharmaceutical Product Information[EB/OL].[2017-07-06]. https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/importsandexportscompliance/ucm348825.htm.
[8]Health Canada. Guidance Document on the Application for a Certificate of a Pharmaceutical Product[EB/OL].(2015-04-01)[2017-07-06]. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/licences/directives/gui-0024-eng.pdf.
[9]Medicines and Healthcare Products Regulatory Agency.Export Drugs and Medicines:Special Rules[EB/OL].[2016-11-11]. https://www.gov.uk/guidance/export-drugsand-medicines-special-rules.
[10]Therapeutic Goods Administration. Policy for the Export of Medicines from Australia[EB/OL].(2014-08-08)[2017-07-06]. https://www.tga.gov.au/sites/default/files/export-medicines-policy.pdf.
[11]Therapeutic Goods Administration. Certificate of Listed Product, Certificate of Pharmaceutical Product&Certificate of Exempt Product[EB/OL].(2007-10-19)[2017-07-06]. https://www.tga.gov.au/certificate-listed-productcertificate-pharmaceutical-product-certificate-exemptproduct.
[12]New Delhi. DCGI to Issue CoPP&WHO Certificates for Export from October[EB/OL].(2009-09-07)[2017-07-06]. http://www.business-standard.com/article/companies/dcgi-to-issue-copp-who-certificates-for-export-fromoctober-109090700160_1.html.
[13]Ramesh Shankar. DCGI Issues Uniform Procedures in Regulatory Inspection for Issuance of CoPP, GMP Certificates[EB/OL].(2014-08-11)[2017-07-06].http://pharmabiz.com/NewsDetails.aspx?aid=83449&sid=1.
[14]国家食品药品监督管理总局,总局办公厅公开征求药品出口销售证明管理规定(征求意见稿)意见[EB/OL].[2016-07-19]. http://www.sda.gov.cn/WS01/CL0778/159724.html.
[15]国家药品监督管理局.关于印发《出具“药品销售证明书”若干管理规定》的通知[EB/OL].(2001-04-26)[2017-07-06]. http://www.sda.gov.cn/WS01/CL0058/9327.html.
[16]裘敏杰,范月萍,董耿,等.医疗器械产品出口销售证明用途及管理建议[J].现代商贸工业,2016,37(10):43-44.
[17]珠海市食品药品监督管理局.药品证明书(CPP)核发[EB/OL].(2014-08-26)[2017-07-06].http://www.gdda.gov.cn/sofpro/cms/previewjspfile/fdazh/cms_0000000000000000434_tpl.jsp?requestCode=284612&CategoryID=1834.
[18]国家食品药品监督管理局.关于印发药品加工出口管理规定(试行)的通知[EB/OL].(2003-07-29)[2017-07-06]. http://www.sda.gov.cn/WS01/CL0058/9342.html.
[19]国家食品药品监督管理总局.关于出口欧盟原料药证明文件有关事项的通知[EB/OL].(2013-05-07)[2017-07-06]. http://www.sda.gov.cn/WS01/CL0844/80444.html.