国内外药品出口销售证明发放制度比较研究-中国药事.PDF

中国药事 2018年11月 第32卷 第11期 1549 国内外药品出口销售证明发放制度比较研究 毛晓芳，齐翔，周凤祥 （上海迪赛诺生物医药有限公司，上海 201203） 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。 关键词： 药品出口销售证明；发放制度；认证范围；申请资料；申请流程；现场检查；药品出口 R95 A 1002-7777(2018)11-1549-09 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.11.015 Comparative Study on Domestic and International Issuing Systems of Certificate for Pharmaceutical Products Export Mao Xiaofang, Qi Xiang, Zhou Fengxiang (Shanghai Bio-Pharmaceutical Co. Ltd, Shanghai 201203, China) Abstract 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: Chinas 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