[关键词]
[摘要]
为加快药品审评审批速度,国家药品监督管理局颁布一系列鼓励药品创新的政策,申请临床试验实行60日默示许可、建立沟通交流机制等制度。通过分析调整后的中药新药审评思路,充分认识药学阶段性研究的必要性,对中药注册申报不同阶段药学研究的侧重点从药材来源、工艺设计、质量标准建立等方面进行阐述,从而加快中药审评审批进程,为中药新药注册申报提供参考。
[Key word]
[Abstract]
A series of policies to encourage innovative drug were issued and implemented in opinions of speeding up new drug review and approval by National Medical Products Administration, including application for drug clinical trials on 60 days of implied permission and the communication mechanism. In this article, we analyzed the adjustment of new drug review, and explained the necessity and difference in pharmaceutical research and development of Chinese materia medica (CMM), and illuminated the main problems and emphases in CMM pharmaceutical research in aspects of source of medicinal materials, production process, quality research and standards, expecting to provide reference for speeding up new drug review and benefit drug applicants.
[中图分类号]
R288
[基金项目]