关于药品安全监管体制建设的思考  

Thoughts on the Construction of Drug Safety Supervision System

作　　者：赵春荷 ZHAO Chun-he(Product Quality Inspection and Testing Center of Xixia County,Henan Province)

机构地区：[1]河南省西峡县产品质量检验检测中心

出　　处：《中国食品药品监管》2024年第7期76-81,共6页China Food & Drug Administration Magazine

摘　　要：药品安全监管体制是指由药品安全相关机构组成的监管体系,从法律法规、注册审批、生产流通监管、处罚和监督机制等方面实行全面管理,保障药品质量与公众用药安全。本文从药品安全监管理念、监管体制建设、监管效能、监管方式等方面,梳理了我国药品安全监管体制的发展历程,探讨了药品安全监管与体制建设的关系,肯定了独立权威的药品安全监管体制的成效,以及认可目前大市场多部门融合的监管体制。同时,科学正视药品安全监管体制发展过程中面临的挑战,探讨基层药品安全监管缺失的原因,剖析存在的安全隐患。本文以发展的理念,提出关于建立科学、高效的药品安全监管体制的思考,以期创新监管方式,强化监管效能,进一步建设科学、务实、先进的药品安全监管体制,从而推动大市场监管体制下的药品安全监管模式焕发新的生机与活力。The drug safety regulatory system refers to the comprehensive management system composed of drug-safety related agencies,which involves aspects such as laws and regulations,registration and approval,production and circulation supervision,punishment,and supervision mechanisms to ensure drug quality and public safety.This paper reviews the development of China's drug safety supervision system,examining the concepts,supervision system construction,efficiency,and methods of supervision.It discusses the relationship between drug safety supervision and system construction,affirming the effectiveness of an independent and authoritative drug safety supervision system and recognizing the current large market multi-department integrated supervision system.At the same time,it also scientifically addresses the challenges faced during the development of the drug safety supervision system,explores the reasons for the lack of grassroots drug safety supervision,and analyzes existing safety risks.This paper puts forward thoughts on the establishment of a scientific and efficient drug safety regulatory system,aiming to innovate regulatory methods,enhance regulatory effectiveness,and further build a scientific,pragmatic,and advanced drug safety regulatory system.The goal is to promote a revitalized and vigorous drug safety supervision model under the large market supervision system.

关 键 词：药品安全监管 体制建设 大市场监管体制 监管理念 监管模式 

分 类 号：R95[医药卫生—药学]