近年申请注册的中药新药生殖毒性研究情况及有关问题分析

Analysis of the reproductive toxicity studies of new Chinese herbal drugs applied for registration in China in recent years and discussion of relevant issues

本文梳理了药品注册相关法规和指导原则对中药新药生殖毒性研究的要求以及我国2008年以来申请注册的中药新药的生殖毒性研究情况,结合当前中药新药研发和审评审批的实际,对有关问题进行了分析。

This paper introduces the requirements for the reproductive toxicity studies of new Chinese herbal drugs in drug registration regulations and related guidelines,and analyzes the situation of the reproductive toxicity studies of new Chinese herbal drugs applied for registration in China in recent years,and then discusses the relevant issues based on the current practical situation of the research and development of new Chinese herbal drugs and their review and approval.