中国食品药品监管Issue(7)：16-25,10.DOI:10.3969/j.issn.1673-5390.2024.07.002
WHO监管评估体系概况及对我国药品监管国际化的思考
Overview of WHO Regulatory Assessment System and Reflection on the Internationalization of China's Drug Regulation
摘要
Abstract
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.关键词
全球基准评估工具/成熟度水平/世界卫生组织列名监管机构/监管能力评估/监管国际化/国际互信/透明度Key words
Global Benchmarking Tool/maturity level/WHO-Listed Authorities/regulatory capacity assessment/regulatory internationalization/international mutual reliance/transparency分类
医药卫生引用本文复制引用
张帆,张志娟,宋瑞霖..WHO监管评估体系概况及对我国药品监管国际化的思考[J].中国食品药品监管,2024,(7):16-25,10.
