关键词:  , 药品监管国际合作；国际人用药品注册技术协调会；药品检查合作计划；监管信赖

Abstract:

As a special commodity， the regulation of pharmaceuticals is crucial for safeguarding public health and national security. With the development of globalization， the pharmaceutical supply chain has transcended national borders， making international regulatory cooperation an inevitability. The internationalization of drug regulation， which makes the Chinese drug regulatory system comprehensively be in line with the global technical standards， is one of the key work to achieve the high quality development of pharmaceutical industry in China as well as the goal to transfer from a country with a big pharmaceutical industry into the one with a strong pharmaceutical industry. The Opinions on Comprehensively Deepening the Regulatory Reform on Drugs and Medical Devices and Promoting the High Quality Development of Pharmaceutical Industry， promulgated by the General Office of the State Council in January 2025， made clear requirements on “deeply promoting the transformation and implementation of international regulatory rules， and provided guidance for the future development of internationalization of drug regulation. This paper reviesw the latest development of internationalization of drug regulation in China， summarizes the development trend on the global practice on drug regulation internationalization and provides pieces of advice on how to implement the opinion and to promote the internationalization of drug regulation in the future， including full participation in the formulation and revision of international rules， promoting regulatory convergence and authoritative assessment， deeply engaging in regulatory trust projects， strengthening regulatory scientific research and talent cultivation， and enhancing international communication capabilities， in order to provide references for the continuous optimization of China's pharmaceutical regulatory system and the high-quality development of China's pharmaceutical regulatory internationalization efforts.

Key words: International cooperation on drug regulation； , ICH； , PIC/S； , Regulatory Reliance