监管科学的学科建设和人才培养

监管科学是被世界卫生组织和美欧日等制药强国高度重视和发展的一门前沿交叉学科,有力提升了药品创新能力和监管效能,已被美国教育部门明确认定为大门类一级学科,初步形成本科、硕士和博士层面完备的教育培养体系。为提高我国药品监管的科技化、法治化、现代化和国际化水平,2019年国家药监局启动"中国药品监管科学行动计划"。明确监管科学学科定位和培养高层次专业人才是促进监管科学可持续发展的基础和根本保障。本文梳理了监管科学在美欧日高校的学科设置、学术研究、人才培养和转化应用情况,对比分析了我国监管科学发展的特点和优势,提出在我国高校设置专业学位、培养监管人才的重要意义和发展路径。

Advancing the Discipline of Regulatory Science and Talent Cultivation

Regulatory science is a frontier interdisciplinary science that has been given much attention by the World Health Organization(WHO),the United States,European countries and Japan.It promotes drug innovation and regulatory efficiency,and has been identified as first-level academic discipline by the U.S.Department of Education.A complete educational curriculum is taking shape,covering bachelor’s,master’s and doctoral degrees.In order to promote modernization and internationalization of China’s drug regulatory system that is based on scientific evidence and laws and regulations,in May,2021,the State Council of the People’s Republic of China issued a document requiring implementation of China’s Drug Regulatory Science Initiative.Developing the discipline of regulatory science and cultivating high-level professional talents provide the basis and guarantee for promoting the sustainable development of regulatory science.This paper summarizes the curriculum design,academic research,talent cultivation and transformation application of regulatory science in universities in the U.S.,Europe and Japan,makes a comparative analysis of the characteristics and advantages of regulatory science development in China,and puts forward the significance and development path of setting up relevant academic degree and cultivating talents in regulatory science in Chinese universities.