中醫(yī)藥作為我國(guó)獨(dú)特的健康資源，在中國(guó)與東盟國(guó)家的交流往來(lái)中占主要地位，是“一帶一路”倡議重要的文化載體。鑒于中藥產(chǎn)品在東盟醫(yī)藥產(chǎn)品出口份額中占比較低，同時(shí)東盟國(guó)家對(duì)中醫(yī)藥的需求呈上升趨勢(shì)，通過實(shí)現(xiàn)中藥產(chǎn)品在東盟國(guó)家的注冊(cè)可以助力中醫(yī)藥企業(yè)“走出去”。對(duì)我國(guó)和東盟（選取馬來(lái)西亞、泰國(guó)、新加坡、印度尼西亞、越南5個(gè)國(guó)家）中藥注冊(cè)申請(qǐng)通用文件和申請(qǐng)程序進(jìn)行總結(jié)和對(duì)比，旨在為“一帶一路”倡議指引下中藥產(chǎn)品的東盟注冊(cè)提供參考，促進(jìn)中醫(yī)藥走向世界，推動(dòng)中醫(yī)藥海外創(chuàng)新發(fā)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年藥品監(jiān)管科學(xué)全國(guó)重點(diǎn)實(shí)驗(yàn)室第二批課題（2024SKLDRS0221）