《药品管理法》颁布四十年回顾与展望  

Review and Prospect of the 40 Years Since the Promulgation of the Drug Administration Law

作　　者：徐景和 XU Jinghe(National Medical Products Administration,Beijing 100037,China)

机构地区：[1]国家药品监督管理局,北京100037

出　　处：《中国药学杂志》2024年第18期1665-1673,共9页Chinese Pharmaceutical Journal

摘　　要：《中华人民共和国药品管理法》(以下简称《药品管理法》)自1984年颁布以来历经2次修订、2次修正。制度演进过程充分体现了药品管理规律认识的不断深化、治理制度的不断完善、治理机制的不断健全、治理方式的不断丰富、法律责任体系的不断完善。2019年版《药品管理法》的修订坚持政治引领、坚持问题导向、坚持国际视野、坚持立足国情、坚持改革创新、坚持科学发展。《药品管理法》颁布及历次修订完善系统折射了我国经济社会和药品产业发展的变迁,充分反映了人民群众健康需求的日益增长,清晰展示了我国社会治理的全面进步。推进药品安全在现代法治轨道上前行,需要准确把握历史方位,完善法律体系,树立执法权威,提升法治素养,为加快推进我国向制药强国跨越提供更加坚实的法律制度保障。The“Drug Administration Law of the People′s Republic of China”has undergone two revisions and two amendments since its promulgation in 1984.The process of institutional evolution reflects the continuous deepening of understanding of drug administration courses,the continuous refinement of governance systems,the continuous improvement of governance mechanisms,the continuous enrichment of governance methods,and the continuous improvement of legal liability systems.The revision of the drug administration law in 2019 adheres to political guidance,problem-oriented approach,international perspective,national conditions,reform and innovation,and scientific development.The promulgation and successive revisions of the drug administration law reflect the changes in China′s economic,social,and pharmaceutical industry development,fully reflecting the growing health needs of the people and clearly demonstrating the comprehensive progress of China′s social governance.To advance drug safety on the track of modern rule of law,it is necessary to accurately grasp the historical position,improve the legal system,establish law enforcement authority,enhance legal literacy,and provide more solid legal system underpinnings for accelerating China′s leap towards becoming a pharmaceutical manufacturing powerhouse.

关 键 词：药品安全 药品管理法 药品治理 制度演进 管理规律 

分 类 号：R951[医药卫生—药学]