Objective To provide a reference for the connection of drug regulatory rules in the Guangdong-Hong Kong-Macao Greater Bay Area(GBA).Methods The registration and post-market drug regulatory elements of imported drugs in mainland China,Hong Kong,and Macau were compared by the policy analysis method,and the similarities and differences were analyzed to explore how to achieve smooth customs clearance and"element circulation"through mutual recognition and rule connection,while ensuring drug quality and safety in the special region with"One Country,Two Systems"and three parallel legal systems.Results and Conclusion The drug regulatory system in the three regions is a solid support for drug quality assurance.Although there are some institutional differences,regional institutional integration can be achieved by exploring internal connections,clarifying the relationship between essence and appearance,and through mutual recognition,thereby solving the problems encountered in institutional implementation.
关键词
粤港澳大湾区/药品进口备案/协同认可/药品监管
Key words
Guangdong-Hong Kong-Macao Greater Bay Area/drug import filing/mutual recognition/drug administration
维普
万方数据