探索建设监管科学研究五大生态圈整章建制协同推进十大领域新工程  

Leveraging Five Supporting Factors to Create Favorable Environment for Regulatory Science Research and Establishing Rules and Systems to Push Forward Ten New Projects

作　　者：毛振宾 何昆仑 欧阳呓林 赵启飞 MAO Zhen-bin;HE Kun-lun;OU-YANG Yi-lin;ZHAO Qi-fei(不详;NMPA Key Laboratory of AI Medical Device Research and Evaluation;Department of Science,Technology and International Cooperation,National Medical Products Administration;College of Traditional Chinese Medicine,Beijing University of Chinese Medicine)

机构地区：[1]不详 [2]国家药品监督管理局人工智能医疗器械研究与评价重点实验室 [3]国家药品监督管理局科技和国际合作司 [4]北京中医药大学中药学院

出　　处：《中国食品药品监管》2022年第5期28-39,共12页China Food & Drug Administration Magazine

摘　　要：本文通过分析国内外药品监管科学的研究现状及发展态势,探讨了构建我国药品监管科学研究的核心引领、科技支撑、部门联动、社会共治和开放共享五大生态圈的建设思路及其相互关系,提出了建立监管科学研究新制度、创新发展新机制,整章建制、协同推进监管科学十大领域新工程。Based on analysis of the current status and development trend of drug regulatory science research at home and abroad,this paper discusses plans for creating a supporting environment in China for drug regulatory science research which entails five elements,namely,core guidance,science and technological support,coordination across departments,social cogovernance and open-sharing,and explores the relationship among these elements.The authors propose to establish a new regimen for regulatory science research and a new mechanism of innovation,and make coordinated efforts under new rules and regulations to push forward development of ten new projects in the area of regulatory science.

关 键 词：监管科学 五大生态圈 整章建制 协同推进 十大新工程 

分 类 号：R95[医药卫生—药学]