我国药品管理立法的制度史演进

Institutional History Evolution of Drug Management Legislation in China

改革开放至今,《药品管理法》作为我国药品管理基本法,经历了从无到有、日臻完善的历程。改革开放初期,我国颁布了《药政管理条例(试行)》,这是我国药品管理立法的先声。随着1984年《药品管理法》的制定和实施,以及特殊药品管理、药品审评、药品生产质量管理等一系列相关法规规章相继发布,我国药品法治体系初具雏形。为适应改革开放以来药品管理领域的新变化,2001年对《药品管理法》进行修订,体现了确保药品安全有效的法律核心价值与现代行政法治的理念和精神,立法技术也日臻完备。2018年吉林长春长生公司问题疫苗案件引发了各界对药品安全的关注,同时,亟待通过完善法律体系以巩固药品审评审批改革成果。2019年对《药品管理法》的修订,是《药品管理法》颁布以来第二次系统性、结构性重大修订,本次修订引入风险管理、鼓励药物创新、深化药品监管体制机制改革等内容,设定更为严格的法律责任,标志着我国药品管理进入全新的现代化时代。本文概述了《药品管理法》的发展历程及我国药品管理的制度变迁,以期为进一步提升我国药品管理水平、保障公众用药安全提供参考。

Since the reform and opening up,the Drug Administration Law,as the foundational legal framework for pharmaceutical administration in China,has evolved from the primitive to the modern era.Initially,during the early reform period,the Regulations on Drug Administration(Trial)were introduced,which laid the groundwork for China's drug management legislation.The Drug Administration Law was enacted and implemented in 1984,along with subsequent regulations and rules on special drug management,drug review,and Good Manufacturing Practice,laying the foundation for China's pharmaceutical legal system.To adapt to the changes since the reform,the Drug Administration Law underwent a revision in 2001,reflecting the core legal values of ensuring drug safety and efficacy,as well as incorporating the principles of modern administrative law.This revision also enhanced legislative techniques.The 2018 Changchun Changsheng vaccine incident heightened public concerns over drug safety,underscoring the need to consolidate the legal framework to support drug approval reforms.The 2019 revision,the second major comprehensive overhaul of the law,introduced elements of risk management,encouraged pharmaceutical innovation,reformed regulatory systems and mechanisms,and established stricter legal liabilities,marking the modernization of China's pharmaceutical management.This paper summarizes the development of Drug Administration Law and the institutional evolution of drug management in China,aiming to provide a reference for further improving drug management and ensuring public drug safety.