摘要
在《药品管理法》颁布实施四十年之际,本文回顾了监管理念、机构和制度变迁,监管成效和对行业的指引和影响.四十年来,药品监管机构不断向现代化和国际化转型,药品监管体系不断完善.在制度优化方面,《药品管理法》以药品上市许可持有人制度、药物警戒制度、检查制度等重大制度变革适应、促进、规范产业高质量发展,极大地强化主体责任.《药品管理法》在规范医药行业及市场秩序、保证药品质量和安全、保障公众用药安全和合法权益等方面发挥了关键作用,取得了突出成就.
Abstract
On the occasion of the 40th anniversary of the promulgation and implementation of the Drug Administration Law,this article reviews the evolution of regulatory philosophy,institutions,and systems,as well as their performance,guidance,and impact on the industry.Over the past 40 years,the drug regulatory agencies have undergone continuous modernization and internationalization,with the drug regulatory system experiencing constant improvement.In terms of institutional optimization,the Drug Administration Law adapts,promotes,and regulates high-quality industry development through major institutional changes,such as the drug marketing authorization holder system,pharmacovigilance system,and inspection system,thereby strengthening industry responsibility.The Drug Administration Law has played a key role in regulating the pharmaceutical industry and market environment,ensuring drug quality and safety,and safeguarding public medication safety and legitimate rights and interests,achieving significant accomplishments.
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