欧美已批药品生产变更研究

摘要/Abstract

摘要： 目的为完善我国已批药品生产变更提供建议。方法研究欧美基于风险级别的方法监管已批药品上市后的变更规定,并分析我国现行变更管理体系中存在的问题。结果欧美采取以风险为基础划分变更事项风险级别的方法 ,加强对高风险生产变更的监管,合理配置监管资源;并在划分风险级别的基础上应用上市后变更管理方案,增加企业对生产变更操作的灵活性和对上市后变更的预测性,增强企业对产品和生产工艺的理解,促进企业应用新技术,节约监管资源和企业变更成本。结论我国应改变统一的生产变更监管方式,采取以风险为基础的监管方式,并采用上市后变更管理方案,增加企业生产变更操作的灵活性,促进企业持续改进和创新药品生产工艺,减轻企业和监管机构的负担。

关键词: 药品生产变更, 以风险为基础, 上市后变更管理方案

Abstract: Objective To put forward some suggestions on post-approval drug manufacturing changes for our country. Methods The USA and EU regulations of post-approval drug manufacturing changes were studied, and our deficiencies on post-approval drug manufacturing changes were analyzed. Results Both USA and EMA classify manufacturing changes based on risks, pay more attention to supervision of changes with high risks, and use post-approval change management protocol to give manufacturers who understand the risks of their products with more flexibility. Conclusion We should apply the risk-based approach to drug manufacturing changes to substitute the present unified regulatory way, thereby alleviate the burden of CFDA and corporations, and use post-approval change management protocol to increase more flexibility on manufacturing changes and promote manufacturs^, continuous improvement and innovation.

Key words: drug manufacturing change, risk-based approach, post-approval change management protocol

中图分类号:

R954

李晓宇, 柴倩雯, 田德龙, 杨悦. 欧美已批药品生产变更研究[J]. 中国药物警戒, 2016, 13(8): 476-481.

LI Xiao-yu, CHAI Qian-wen, TIAN De-long, YANG Yue. Research on USA and EU Regulations of Post-approval Drug Manufacturing Changes[J]. Chinese Journal of Pharmacovigilance, 2016, 13(8): 476-481.

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