贯彻“四个最严” 严守药品安全——新修订《中华人民共和国药品管理法》宣贯

Implement ″the Four Strictest Principles″ and Strictly Observe Drug Safety—— Publicity and Implementation of the Newly Revised Drug Administration Law of the People’s Republic of China

目的宣传贯彻新修订的《药品管理法》,确保人民群众用药安全有效。方法分析新修订《药品管理法》的制度框架、相关条款,介绍修订的原则、思路,以及修订的主要内容。结果新修订的《药品管理法》强调了药品管理应当以人民健康为中心、坚持风险管理、全程管控、社会共治的原则,主要修订内容包括法律框架结构、药品定义与分类、鼓励创新、对药品管理实行药品上市许可持有人制度、明确监管事权、假劣药定义及法律责任、严格管理与细化规范、药品储备和供应、监管能力建设、地方人民政府责任等方面。结论《药品管理法》的修订,以立法助推改革,以法治保障民生,在保障公众用药权益、激励产业创新发展方面必将发挥极其重要的作用。

Objective To publicize and implement the newly revised Drug Administration Law,to ensure the safety and effectiveness of medication usage for the people.Methods The institutional framework and relevant provisions of the newly revised Drug Administration Law were analyzed,the principles,ideas and main contents of the revised law were introduced.Results Newly revised Drug Administration Law emphasized the principles of people’s health as the center of drug administration,risk management,whole process control and social co-governance.The main revised content includes the legal framework structure change,the scientific definition of drugs and classification,encourage innovation,implementation of listing permit holders system,clear supervision authority,definition and legal responsibility of fake and substandard drugs,strict management and detailed specifications,medication reserve and supply,supervision capacity and local people’s government responsibility,etc.Conclusion The revision of the Drug Administration Law will promote reform through legislation and ensure people’s livelihood through the rule of law.It will certainly play an extremely important role in protecting the rights and interests of the public in drug use and stimulating industrial innovation and development.