药品作为特殊商品，其监管对保障公众健康和国家安全至关重要。随着全球化发展，药品供应链跨越国界，国际监管合作成为必然。药品监管国际化工作，推动中国监管与国际通行技术标准全面接轨，是推动中国医药产业高质量发展，实现从制药大国向制药强国转变的重要工作。2025年1月，国务院办公厅发布《关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》，对于“深入推进国际通用监管规则转化实施”提出了明确要求，为中国药品监管国际合作指引了下一步前进的方向。本研究梳理近年来我国药品监管国际化工作的最新进展，归纳总结当前全球药品监管国际化的发展趋势，并对落实国办文件进一步推动药品监管国际化工作提出对策和建议，包括全面参与国际规则制修订、推进监管接轨与权威评估、深度参与监管信赖项目、加强监管科学研究与人才培养以及提升国际传播能力，以期为我国药品监管体系的持续优化，推动我国药品监管国际化工作高质量发展提供参考。

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.