摘要
目的:研究欧盟分散审批与互认审批药品(DCP/MRP)市场监督抽检策略,为我国完善省级药品抽检,进一步探索国抽与省抽统筹模式提供参考。方法:采用文献研究法,汇总欧盟分散审批与互认审批药品(DCP/MRP)市场监督抽检相关法规框架、程序性文件等信息,讨论并分析关键措施。结果:欧盟建立了风险评估制度框架与指导通则,形成了基于互评制度的计划管理模式,制定了针对检验协作网络的专项质管体系,搭建了单点协作的假劣药品管控平台以及多元开放的转化应用链条。结论:研究欧盟分散审批与互认审批药品(DCP/MRP)市场监督抽检采取的关键措施,对我国完善省级药品抽检管理,具有一定参考价值。
Objective:To provide references for China to improve provincial drug sampling and testing activities(DSTA),and further explore the national and provincial DSTA mode.This paper studies the post-marketing surveillance strategy of Decentralized Procedure and Mutual Recognition Procedure(DCP/MRP)for drugs in the EU.Methods:Using the literature research method,the relevant regulatory framework,procedural documents and other information related to post-marketing surveillance of DCP/MRP in the EU were summarized,and key measures were discussed and analyzed.Results:The EU has established a risk assessment institutional framework and general principles,formed a plan management model based on the mutual evaluation system,formulated a special quality control system for the inspection collaboration network,built a single-point collaborative counterfeit and inferior drug control platform and a diversified and open transformation and application chain.Conclusion:The study of the key measures taken by the EU DCP/MRP post-marketing surveillance has certain reference value for improving the provincial drug sampling and testing management in China.
作者
郗昊
朱炯
王翀
Xi Hao;Zhu Jiong;Wang Chong(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药事》
CAS
2023年第4期469-479,共11页
Chinese Pharmaceutical Affairs
关键词
欧盟分散审批与互认审批药品
法律法规
省级药品抽检
药品质量
市场监督
EU Decentralized Procedure and Mutual Recognition Procedure for drugs
laws and regulations
provincial drug sampling and testing activities
quality of medicines
post-marketing surveillance