基于新法规下的中药创新药研发策略

Research and development strategies of new Chinese medicines based on new regulations

近年来获批上市的中药新药数量较少,成为制约中药产业发展的瓶颈。针对上述情况,国家药品监督管理局颁布了一系列法规及技术要求。该文在新法规的形势下,深入剖析新注册分类指导下的中药创新药研发策略,并对研发过程中的关键技术问题进行分析和探讨。

In recent years, only a small number of new Chinese medicines have been approved for marketing, which has embodied the bottleneck in the development of the Chinese medicine industry. To tackle this problem, the National Medical Products Administration has issued a series of regulations and technical requirements. In the context of new regulations, this study deeply explored the research and development strategies of new Chinese medicines under the guidance of the new classification of drug registration, and discussed the key technical issues in the research and development.