文章摘要
施绿燕,柳涛,朱佳娴.药品上市许可持有人制度下药品上市后监管风险分析及监管对策研究[J].中国药事,2019,33(8):851-856
药品上市许可持有人制度下药品上市后监管风险分析及监管对策研究
Regulatory Risk Analysis and Countermeasures Study of Post-Marketing Drugs Under Marketing Authorization Holder System
投稿时间:2019-05-14  
DOI:10.16153/j.1002-7777.2019.08.002
中文关键词: 药品上市许可持有人制度  监管风险  监管对策
英文关键词: marketing authorization holder system  regulatory risk  regulatory countermeasure
基金项目:
作者单位E-mail
施绿燕 上海药品审评核查中心, 上海 201203  
柳涛 上海药品审评核查中心, 上海 201203  
朱佳娴 上海药品审评核查中心, 上海 201203 zhujiaxian@smda.sh.cn 
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中文摘要:
      目的:为提升药品上市许可持有人制度下药品上市后监管的效能,本文提出了药品上市后各环节的监管对策,为完善我国药品上市许可持有人制度提供参考。方法:结合上海市试点情况,对药品上市许可持有人制度下药品上市后生产、流通、不良反应监测与评价各环节进行风险识别和风险分析,提出相应的监管策略。结果与结论:在药品上市许可持有人制度下,建议通过制定药品上市许可持有人信息上报制度,建立持有人基础数据库和药品信息追溯体系,在对持有人日常监管中从优化监管资源配置、明确日常监管检查重点、建立跨省监管合作的沟通和协调机制等方面,提升对药品上市后的监管效能。
英文摘要:
      Objective:To put forward regulatory countermeasures for post-marketing drugs in order to improve the regulatory effectiveness of post-marketing drugs under marketing authorization holder system and provide references for improving the marketing authorization holder system in China. Methods:Based on the pilot situation in Shanghai, the risk identification and risk analysis of the production, circulation, adverse reaction monitoring and evaluation of the post-marketing drugs under the marketing authorization holder system were carried out, and corresponding regulatory countermeasures were proposed. Results and Conclusion:In order to improve the effectiveness of regulation of post-marketing drugs under the marketing authorization holder system, it was proposed to establish an information reporting system, a basic database of marketing authorization holders, a drug information traceability system as well as an optimization of the regulatory resources allocation, a clarification of the routine inspection key point, and an establishment of a communication and coordination mechanism of cross-provincial regulatory cooperation were also suggested.
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