中国食品药品监管Issue(2)：70-77,8.DOI:10.3969/j.issn.1673-5390.2025.02.007
粤港澳大湾区背景下内地与港澳中成药注册管理协同化发展的探讨
Discussion on the Synergetic Development of Chinese Patent Medicines Registration Management Between Mainland China and Hong Kong/Macao Under the Guangdong-Hong Kong-Macao Greater Bay Area Framework
摘要
Abstract
Objective:This paper systematically compares the Chinese patent medicines(PCM)registration management system in Mainland China,Hong Kong and Macao to provide references for their synergetic development.Methods:By reviewing literature and analyzing current policies and regulations,the differences and similarities in basic requirements,application materials,and registration process across the three regions were analyzed.Results:All three places implement a classified registration system for PCM,with overall consistency in registration categories.However,differences exist in specific application requirements and registration procedures.Conclusion:Key challenges in harmonizing PCM registration management include inconsistencies in registration criteria,lack of mutual recognition of approval results,and gaps in regulatory frameworks.To address these issues,this paper suggests establishing regional evaluation criteria,developing a flexible registration system,and improving full-cycle legal norms.关键词
粤港澳大湾区/中成药注册/协同发展/挑战/建议Key words
Guangdong-Hong Kong-Macao Greater Bay Area/Chinese patent medicine registration/synergetic development/challenge/suggestion分类
医药卫生引用本文复制引用
邓雯姬,许广宁,李书聪..粤港澳大湾区背景下内地与港澳中成药注册管理协同化发展的探讨[J].中国食品药品监管,2025,(2):70-77,8.
