【摘要】 监管科学作为一门新兴学科,是药品科学监管的重要基础,逐渐受到药品监管部门和医药企业的高度重视。由于该学科在我国处于初步构建和发展阶段,从源头上思考并解决监管科学发展中存在的问题迫在眉睫。本文结合我国药品监督管理的现状,剖析了现阶段我国监管科学发展中亟需加强的几个方面,包括重视引入和应用基础学科(如统计学、风险分析和法律学)的理论、强化跨学科人才的培养、制定配套激励政策等,据此提出相应建议及对策。期望本文能起到抛砖引玉的作用,引发更多学者参与并深入研究监管科学,使我国监管科学学科发展迈上新台阶。更多还原

【Abstract】 As an emerging discipline,regulatory science is an important basis for scientific drug supervision,and is drawing attention from drug regulatory departments and pharmaceutical enterprises.Since regulatory science is in the initial stage of development in China,it is important to think about the problems hindering its development and the solutions.Based on the current situation of drug regulation in China,this paper analyzes several aspects that need to be strengthened in the development of regulatory science in China,including attaching great importance to the introduction and application of basic research subjects,such as statistics,risk analysis and legal studies,strengthening the cultivation of interdisciplinary talents,developing incentive policies,etc.Suggestions are then proposed in each area.It is hoped that this article could inspire more scholars to participate in regulatory science research,and bring it to a new level in China.更多还原