欧盟DCP/MRP药品市场监督抽检策略研究

Research on the Strategy of EU DCP/MRP Post-Marketing Surveillance

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.