新法规下化学药品注册标准变更相关要求

Discussion on the relevant requirements for the change of chemical drug registration standards under the new regulations

药品注册标准是药品注册证书的重要组成部分,其变更的相关要求受到医药行业的广泛关注。本文通过研究现行《药品注册管理办法》和《已上市化学药品药学变更研究技术指导原则(试行)》,对新法规下化学药品注册标准变更的基本要求、变更原因和研究验证内容等进行了讨论和总结,为化学药品注册标准的规范变更提供参考。

The drug registration standard is an important part of the drug registration certificate.By studying the current Drug Registration Management Measures and Technical Guidelines for the Research on Pharmaceutical Changes of Listed Chemical Drugs(Trial),this paper discussed and summarized the basic requirements,reasons for change and research verification contents of the change of chemical drug registration standards under the new regulations,so as to provide reference for the normative change of chemical drug registration standards.