Overview of WHO Regulatory Assessment System and Reflection on the Internationalization of China's Drug Regulation
To address the challenges posed by the complex global regulatory environment and promote global regulatory coordination of medical products,the World Health Organization(WHO)has developed a unified Global Benchmarking Tool(GBT)and released a list of WHO-Listed Authorities(WLAs).This provides a transparent and evidence-based path for regulatory agencies to gain global recognition.China has long prioritized exchanges and cooperation with the WHO,achieving fruitful results in vaccine regulation and globalization.In the field of drug regulation,China has reshaped its entire drug regulatory ecosystem and developed the ability to independently review innovative medical products,but these achievements have yet to gain widespread international recognition.From the perspective of regulatory transparency,which is a key focus of the GBT and WLAs,this article explores the challenges faced by China's drug regulatory system and proposes suggestions to help China more deeply integrate into the international trend of regulatory collaboration and reliance.
Global Benchmarking Toolmaturity levelWHO-Listed Authoritiesregulatory capacity assessmentregulatory internationalizationinternational mutual reliancetransparency
国家科技期刊平台
NSTL
万方数据
