Toward more effective coordination of drug clinical trials in the Greater Bay Area

Abstract

This paper explores the lack of coordination on drug clinical trials in the Greater Bay Area, encompassing Guangdong, Hong Kong, and Macao. Despite growing regional cooperation in the field of biomedicine and biopharmaceuticals, coordinated drug clinical trial governance across the three jurisdictions remains largely disjointed, with separate approval systems, ethics review processes, and deeper obstacles such as compliance burdens and talent-related issues. Drawing lessons from the European Union’s experience, the paper argues that harmonization and simplification of regulatory standards can enhance coordination efficiency and effectiveness. It recommends an approach in which the three regions develop a mutually agreeable framework while aligning with top-level design and strategic priorities set by Mainland, as well as international standards. This coordinated model could pave the way for the Greater Bay Area to become a leading hub for internationally recognized high-quality clinical research.