新形势下原料药、药用辅料和药包材日常监管策略研究  

Regulatory strategies for day-to-day supervision on active pharmaceutical ingredients, pharmaceutical excipients and packaging materials under the new situation

作　　者：李小芬 吴浩 朱娟 朱嘉 廖萍 葛渊源 王晓曦 李帅 LI Xiaofen;WU Hao;ZHU Juan;ZHU Jia;LIAO Ping;GE Yuanyuan;WANG Xiaoxi;LI Shuai(Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China)

机构地区：[1]上海药品审评核查中心,上海201203

出　　处：《上海医药》2019年第7期6-9,22,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：通过网站查询、问卷调查和座谈会调研,梳理上海市原料药、药用辅料和药包材(以下简称为"原辅包")生产企业在国家实行关联审评审批制度后的现状及出现的问题。原辅包生产企业和药品制剂生产企业应落实各自的主体责任,建立战略合作伙伴关系,合力控制药品质量风险,确保药品的质量和安全性。药品监管部门应基于风险原则,对原辅包生产企业和药品制剂生产企业进行日常监管。Based on literature retrieve, data inquiry and questionnaire investigation, current situation and issues about manufacturing enterprises of active pharmaceutical ingredients (APIs), pharmaceutical excipients and packaging materials (APEPM) in Shanghai were summarized after the implementation of evaluation and approval of APEPM associated with drug products. The manufacturing enterprises of APEPM, as well as pharmaceutical manufacturing enterprises, should implement their own responsibilities, establish strategic partnership with each other, work together to control drug quality risks and ensure the quality and safety of drugs. Based on the principle of risk, regulatory authorities should conduct day-today supervision on the manufacturing enterprises of APEPM, as well as pharmaceutical manufacturing enterprises.

关 键 词：原料药 药用辅料 药包材 日常监管 

分 类 号：R95[医药卫生—药学] R951