美国监管科学发展简介及对我国食品药品科学监管的思考

Introduction to US Regulatory Science and Some Considerations for China Food and Drug Scientific Regulation

目的对美国"监管科学"学科的发展现状进行了简要介绍,为我国该学科的建设及发展提供参考。方法检索、介绍美国FDA对该学科的研究现状和未来规划;美国的大学和其他学术机构的研究与教学内容;然后,对我国"监管科学"学科的建立和规划提出个人的一些思考。结果与结论在医用制品快速、大量出现的今天,监管科学在促进食品药品的科学检验和监管中发挥着越来越重要的作用,一些国外药品监管机构(如FDA)甚至把它作为21世纪重点推动的一个学科。我国在构建和发展监管科学学科时,应特别重视:(1)对国外"监管科学"精髓的引进,并根据自己的监管制度形成有特色的学科内容;(2)重视监管科学所需工具的基础性研究投入;(3)重视术语研究和转化的准确性、规范性;(4)重视国外监管法规的学习和引入;(5)设立专项研究基金;(6)重视与大专院校联合,设置相关学科,大力培育人才。

Objective The status of Regulatory Science in USA was briefly introduced to provide references for the development of this subject in China. Methods The current status and future plan of Regulatory Science by the Food and Drug administration of USA, as well as the research and training programs in the universities and academia of USA were searched and introduced. Based on these results, several proposals were put forward on how to plan and develop this branch of learning in China. Results and Conclusion Regulatory Science has become more and more important for improving food and drug testing and regulatory control with the quick arising and fast development of medical products. It has been selected as a key subject to be promoted in the 21St century by some regulatory administrations （such as FDA）. Meanwhile, during the development of Regulatory Science in China, we should attach importance to the followings ： （ 1 ） Introduce the quintessential content of Regulatory Science into China, and develop unique contents based on Chinese regulations; （2） Invest in the basic research for the tools of Regulatory Science; （3） Study and standardize the related terms of Regulatory Science; （4） Study and import some regulations and guidelines from foreign countries; （5） Set up special funds for Regulatory Science; and （6） Cooperate with universities and colleges to set up related subjects and cultivate more specialists.