基于全生命周期理念的中药新药监管科学研究

中药是我国具有原创性优势的健康资源,近年来,国家高度重视中医药的价值,强调传承精华,守正创新以推动中医药行业的健康发展。但目前中药仍面临创新能力不足、中药新药发展缓慢的问题,严重制约中药产业的发展。中药新药研发具有政策导向性,全生命周期管理理念的运用和监管科学的兴起,将会促进中药监管体系与治理能力的发展,为中药研发提供政策指导。对中药全生命周期各阶段的特殊性及监管情况进行分析,探索中药监管科学建设思路,以期为改善中药新药监管效果提供参考。

Research on regulatory science of new Chinese medicine based on concept of whole life cycle

Traditional Chinese medicine (TCM) is preponderant health resource in China with originality. Recently, our country attaches great importance to the value of TCM, emphasizing inheriting essence, keeping integrity and innovation to promote the healthy development of TCM industry. But at present, TCM is still faced with the problem of insufficient innovation ability and slow development of new medicines, which seriously restricts the development of TCM industry. The research and development of new TCM is policy-oriented, the application of the whole life cycle management concept and the rise of regulatory science will promote the development of TCM regulatory system and governance capacity, and provide a policy guide for TCM research and development. This paper analyzes the particularity and supervision situation of the whole life cycle of TCM, and explores the construction ideas of the regulatory science of TCM to provide reference for improving the supervision effect of new medicines of TCM.