中医药作为我国独特的健康资源，在中国与东盟国家的交流往来中占主要地位，是“一带一路”倡议重要的文化载体。鉴于中药产品在东盟医药产品出口份额中占比较低，同时东盟国家对中医药的需求呈上升趋势，通过实现中药产品在东盟国家的注册可以助力中医药企业“走出去”。对我国和东盟（选取马来西亚、泰国、新加坡、印度尼西亚、越南5个国家）中药注册申请通用文件和申请程序进行总结和对比，旨在为“一带一路”倡议指引下中药产品的东盟注册提供参考，促进中医药走向世界，推动中医药海外创新发展。

As a unique and valuable health resource of China, traditional Chinese medicine (TCM) plays a major role in the exchanges between China and Association of Southeast Asian Nations (ASEAN) countries and serves as a key cultural carrier of the Belt and Road Initiative. Given that the market share of TCM exports in ASEAN countries is relatively low and the demand for TCM in ASEAN countries is on the rise, the registration of TCMs in ASEAN countries can help Chinese medicine enterprises “go global”. Therefore, this paper summarizes and compares the general dossiers and application procedures of TCM registration between China and ASEAN (Malaysia, Thailand, Singapore, Indonesia and Vietnam), aiming at providing reference for ASEAN registration of TCMs under the “Belt and Road” policy, promoting overseas innovation and development of TCM.

2024年药品监管科学全国重点实验室第二批课题（2024SKLDRS0221）