多维度认识监管科学作用,推动药监工作高质量发展  

Multi-Dimensional Understanding of the Role of Regulatory Science,to Promote the High-Quality Development of Drug Supervision

作　　者：聂淑华 涂明珠 Nie Shuhua;Tu Mingzhu(Jiangxi Drug Inspection Center,Jiangxi Institute for Drug Control,Nanchang 330029,China)

机构地区：[1]江西省药品检查员中心,江西省药品检验检测研究院,南昌330029

出　　处：《中国药事》2024年第11期1269-1274,共6页Chinese Pharmaceutical Affairs

基　　金：江西省药品监督管理局科研项目(编号2023GL14)。

摘　　要：目的:分析监管科学的作用,对我国药品监管科学的研究与发展作出阐释,在此基础上提出要重视发挥监管科学的作用,推动实现药品安全治理体系和治理能力的现代化。方法:通过查询相关文献和法律法规,多方面分析研究监管科学和药品监管的起源、现状和发展。结果:通过研究,充分认识监管科学的巨大作用,以推动我国药品监管工作高质量发展。结论:我国药品监管工作要实现高质量发展,就要从药品审评审批、检验检查、监测评价、体制机制、队伍建设等药品全生命周期的各个方面综合发力,多措并举,善作善为。Objective:To analyze the role of regulatory science and expound the research and development of drug regulatory science in our country,so as to put forward that we should pay attention to the role of regulatory science and promote the modernization of drug safety governance system and governance capacity.Methods:The origin,current situation,and development of regulatory science and drug regulation were analyzed and studied from multiple perspectives by searching relevant literature laws and regulations.Results:In this study,we understood the great role of regulatory science in depth to promote the high-quality development of drug regulatory work in our country.Conclusion:In order to achieve high-quality development of drug supervision in our country,it is necessary to exert comprehensive efforts in all aspects of drug life cycle,such as drug evaluation and approval,inspection and inspection,monitoring and evaluation,system and mechanism,team building,and take many measures and do good deeds.

关 键 词：监管科学 作用 监管体制 融合 建议 

分 类 号：R95[医药卫生—药学]