国际药品监管科学起源、定义与特征的若干思考

Some thoughts on the origin,definition,and characteristics of international drug regulatory science

药品监管科学是近年来国际社会高度关注的药品领域的前沿课题。目前,不同国家和地区药品监管产业基础不同、发展阶段不同、面临的突出问题不同,药品监管科学关注的重点和需要破解的难题也有所不同。药品监管科学起源的观点启示,要从新时代的到来和新力量的产生深入思考药品监管科学的出现与发展。药品监管科学定义和特征的论点启示,要围绕聚焦药品监管规律、围绕监管突出问题、服务监管科学决策来推动和发展监管科学,开发监管新工具、新标准和新方法,培育监管新理念、新制度和新机制。

Drug regulatory science is a cutting-edge task in the field of drug regulation that has received much attention from the international community in recent years.Currently,different countries and regions have different foundations for drug regulatory industries,are in different stages of development,and face different prominent issues.Therefore,the focus of drug regulatory science and the problems that need to be solved are also different.The origin of drug regulatory science suggests that we should deeply consider the emergence and development of drug regulatory science from the perspective of the arrival of a new era and the emergence of new forces.The definition and characteristics of drug regulatory science suggest that it is a practical science that solves prominent problems and directly serves regulatory decision-making,and future studies should focus on drug regulation rules,develop new regulatory tools,standards and methods,and cultivate new theories,regulations and mechanism.