监管科学在促进生物医药产业发展中的作用  

The role of drug regulatory science in promoting the development of the bio-pharmaceutical industry

作　　者：陈一飞 李香玉 陈桂良 CHEN Yifei;LI Xiangyu;CHEN Guiliang(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)

机构地区：[1]上海药品审评核查中心,上海201203

出　　处：《上海医药》2020年第13期10-14,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：生物医药产业的健康发展是保障公众生命安全,提高民众生活质量的重要支撑。如何通过生物医药产业的健康积极发展,保障人民用药安全、可及是目前药品监管科学的思考重点。药品监管科学的兴起与发展,将会通过对科学监管的促进达到完善药品治理体系、提高药品治理能力的目的。本文对药品监管科学的发展背景与国际现状进行综述,以期为我国药品监管科学的学科建设及转化应用提供借鉴与参考。The healthy development of the bio-pharmaceutical industry is an important support for ensuring the safety of the public’s lives and improving the quality of life of the people.How to ensure the safety and accessibility of drugs to the people is the focus of the current drug regulatory science.The rise and development of drug regulatory science will achieve the goal of improving drug management system and drug management capability by the promotion of scientific supervision.This article reviews the development background and international situation of drug regulatory science so as to provide reference for the discipline construction and transformation application of drug regulatory science in China.

关 键 词：药品 监管科学 FDA EMA 

分 类 号：R95[医药卫生—药学]