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。
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.
作者
施绿燕
柳涛
朱佳娴
Shi Lvyan;Liu Tao;Zhu Jiaxian(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)
出处
《中国药事》
CAS
2019年第8期851-856,共6页
Chinese Pharmaceutical Affairs
关键词
药品上市许可持有人制度
监管风险
监管对策
marketing authorization holder system
regulatory risk
regulatory countermeasure
