《药物生殖毒性研究技术指导原则》与ICH S5(R2)指导原则的对比研究及实施建议

Comparison on guideline from CDE/ICH S5(R2) and suggestions for reproductive toxicity study and feasibility of implementation in domestic

介绍国家食品药品监督管理总局药品审评中心(CDE)和人用药品注册技术要求国际协调会(ICH)对药物生殖毒性研究指导原则的内容,比较不同机构对生殖毒性非临床评价要求,包括ICH S5(R2)指导原则和国内相关领域指导原则的对应关系、我国指导原则与ICH S5(R2)的差异等内容,对ICH S5(R2)在我国实施的可行性存在的技术困难和法规方面的障碍进行了讨论,并根据CDE和ICH指导原则的差异对比情况对我国实施ICH S5(R2)给出了建议,以期为国内新药的生殖毒性评价提供借鉴。

The guidelines for reproductive toxicity for medicinal products from CDE and ICH were reviewed in this paper. The requirements of non-clinical evaluation reproductive toxicity were compared between different agencies, including the relationship and differences between ICH S5（R2） guideline and the corresponding related field in domestic. Meanwhile the technical difficulties of ICH S5（R2） in the feasibility of implementation in domestic and the obstacles involved laws and regulations were discussed. Then according to the guidelines comparison between the CDE and ICH, suggestions were expected to supply reference for the local reproductive toxicity study.