国外药品监管科学技术支撑体系研究及思考

药品监管科学于上世纪90年代初步完成学科构建，并受到世界卫生组织认可，世界各主要发达国家均高度重视并积极推动成为一门新兴前沿科学；是一个高度交叉融合、支撑服务监管的学科理论体系、知识体系和学术体系；核心是研发评价药品安全有效性的新技术、新工具和新方法的创新实践活动；重点是建设药品监管治理体系和治理能力现代化、科技化、法治化和国际化的系列工程。笔者通过对国外监管科学技术支撑机构和合作单位等有关情况的调研，初步厘清了当前世界监管科学技术支撑体系发展的现状和成就，并对我国药品监管科学机构的发展进行思考，提出建议。

Research on Science and Technology Support System of Drug Regulatory in Foreign Countries

The construction of drug regulatory science was initially completed in the 1990s and recognized by the World Health Organization. Major developed countries in the world have attached great importance to it and have promoted it to become a new frontier science. It is a highly interdisciplinary theoretical system, knowledge system and academic system supporting service supervision. Its core is to develop new technologies to evaluate the safety and effectiveness of drugs. The focus is to build a series of projects of modernization, scientization, legalization and internationalization of drug regulatory governance system and governance capacity. Based on the investigation of foreign regulatory science and technology support institutions and cooperation units, the author preliminarily clarified the current situation and achievements of the development of regulatory science and technology support system in the world, and put forward suggestions for the development of drug regulatory science institutions in China.