基于因素分析的药品监管科学研究体系建设探讨

Discussion of factors analysis-based scientific research system for regulatory science

药品监管的核心是对药品相关活动的评价及做出相应的决策。药品监管科学是如何科学规范的进行评价和决策的科学。近年来药品监管科学逐渐发展且越来越受到各国药品监管机构的重视。以FDA、EMA为代表的先进国家药品监管机构均在进行药品监管科学研究,并用于指导实践工作。在生物医药行业不断全球化高速发展的形式下,如何通过构建监管科学研究体系来推动监管决策的科学性是急需要解决的问题。为了应对国际化监管的需求和新方法新技术的挑战,本文从研究的主体、研究的实施路径、研究的内容、基础学科建设等几个因素,分析探讨我国监管科学体系建设可能开展的工作,为我国药品监管科学的发展提供参考。

The core of drug regulation is to evaluate drug-related activities and make corresponding decisions.The science of drug regulation is how to scientifically and standardly conduct evaluation and decision-making and has been gradually developed and increasedly focused on by drug regulatory agencies of various countries in recent years.The developed national drug regulatory agencies represented by FDA and EMA are conducting regulatory scientific research and their research results will be used to guide practice.How to promote the scientific nature of regulatory decision-making through the construction of regulatory scientific research system in the form of continuous globalization of biopharmaceutical industry is an urgent problem to be solved.In order to meet the needs of international supervision and the challenges of new methods and technologies,this paper analyzes and discusses the possible work in the construction of regulatory science system in China from the aspects of the main body of research,the way of research implementation,the content of research and the construction of basic disciplines so as to provide reference for the development of drug regulatory science in China.