| 郗昊,朱炯,王翀.欧盟DCP/MRP药品市场监督抽检策略研究[J].中国药事,2023,(4):469-479 |
| 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 |
| |
| DOI：10.16153/j.1002-7777.2023.04.014 |
| 中文关键词: 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 |
| 英文关键词: EU Decentralized Procedure and Mutual Recognition Procedure for drugs laws and regulations provincial drug sampling and testing activities quality of medicines post-marketing surveillance |
| 基金项目: |
|
| 摘要点击次数: 846 |
| 全文下载次数: 312 |
| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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 diversifi ed 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. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |