中药注册申报中非临床研究资料常见问题探讨

Discussion of common problems in nonclinical study reports in the registration of traditional Chinese medicine

近年来,我国陆续出台中药产业支持政策,对中药新药研发带来了新的发展机遇,2020年9月国家药品监督管理局发布了《中药注册分类和申报资料要求》,对中药注册申报提出了新的要求。非临床研究资料作为在中药注册申报资料重要的组成部分,是中药开展临床试验或上市重要的有效性和安全性的依据。本文结合《中药注册分类和申报资料要求》,对中药注册申报资料中发现的常见问题进行分析和探讨,以期为中药研发和注册申报提供参考。

In recent years, China has successively introduced policies to support the traditional Chinese medicine(TCM) industry,which has brought new development opportunities for research and development(R&D) of new TCMs. In September 2020, the National Medical Products Administration released the Registration Classification and Declaration Requirements for Traditional Chinese Medicine, which put forward new requirements for the registration declarations of TCMs. As an essential part of information in the registration of TCMs, the nonclinical study reports are one of the most important of evidences for efficacy and safety of investigational new drug or new drug application of TCM. By combining the Registration Classification and Declaration Requirements for Traditional Chinese Medicine, this article analyzed and discussed the common problems that were found in TCMs application, so as to provide a reference for the R&D and registration of TCM.