基于粤港澳大湾区药品监管创新视角的内地与香港地区、澳门地区中药注册管理体系对比及协同发展思考

A Comparative Study and Synergy Development Thinking of Traditional Chinese Medicine Registration System between China's mainland and HongKong region/Macao region Based on the Guangdong-HongKong region-Macao region Bay Area Drug Regulatory Innovation Perspective

本文通过文献分析,对比内地(以广东省为例)与香港地区、澳门地区在中药注册行政管理体系、法律法规体系和注册分类等方面的异同。结合粤港澳大湾区药品医疗器械监管创新发展工作实践,提出支持粤港澳三地中药产业协同发展,并以港澳为“窗口”促进内地中药产品国际化、现代化,推动内地医疗机构制剂成果转化的思考和建议。

This study conducts a comparative analysis of the administrative system,legal system and registration classification of traditional Chinese medicine between China's mainland(using Guangdong province as an example)and HongKong region/Macao region,through literature review.Based on the practice of drug and medical device regulatory innovation and development in the Guangdong-HongKong region-Macao region Bay Area,this paper proposes to support the coordinated development of traditional Chinese medicine industry in Guangdong,Hong Kong and Macao,and to use HongKong region and Macao region as a“window”to promote the internationalization and modernization of Chinese medicine products in China's mainland.Additionally,this paper suggests promoting the transformation of the results of Mainland medical institutions.