[關(guān)鍵詞]
[摘要]
中醫(yī)藥作為我國獨特的健康資源,在中國與東盟國家的交流往來中占主要地位,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,同時東盟國家對中醫(yī)藥的需求呈上升趨勢,通過實現(xiàn)中藥產(chǎn)品在東盟國家的注冊可以助力中醫(yī)藥企業(yè)“走出去”。對我國和東盟(選取馬來西亞、泰國、新加坡、印度尼西亞、越南5個國家)中藥注冊申請通用文件和申請程序進行總結(jié)和對比,旨在為“一帶一路”倡議指引下中藥產(chǎn)品的東盟注冊提供參考,促進中醫(yī)藥走向世界,推動中醫(yī)藥海外創(chuàng)新發(fā)展。
[Key word]
[Abstract]
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.
[中圖分類號]
[基金項目]
2024年藥品監(jiān)管科學(xué)全國重點實驗室第二批課題(2024SKLDRS0221)