摘要
2019年8月《中华人民共和国药品管理法》迎来了第2次系统性修订,力求为药品管理提供更加有力的法制保障。此次修订坚持以公众健康为落脚点,建立了科学严格的法律制度,通过保证药品质量,进而保障公众用药安全和合法权益,对我国推进药品安全治理科学化、现代化、法制化进程意义重大。本文以保障患者用药安全为切入点,通过对法律总则与核心条款的分析,解读了新制度语境下法律架构、同情用药、药品上市许可持有人制度、违法行为的法律责任、生产质量管理规范(GMP)动态检查制度和假药新定义等问题。
In order to establish a more powerful legal guarantee for drug administration, the Drug Administration Law of the People′s Republic of China (PRC) was revised systematically for the second time in August 2019. In this revision, taking public health as its foothold, a scientific and strict legal system was established to guarantee the medication safety and legitimate right of the public by ensuring the quality of drugs, which is of great significance to promote the scientific, modern, and legal process of drug safety management in China. In this paper, taking medication safety of patient as starting point, through analysis on the general principles and core clauses of the law, the legal framework, sympathetic drug use, marketing authorization holder system, legal liability for illegal acts, Good Manufacture Practice of Medical Products (GMP) dynamic inspection system, and new definition of counterfeit drugs in the context of the new drug administration law were interpreted.
作者
邵蓉
陶田甜
Shao Rong;Tao Tiantian(The Research Center of National Drug Policy & Ecosystem,China Pharmaceutical University,Nanjing 211198,China)
出处
《药物不良反应杂志》
CSCD
2019年第5期377-380,共4页
Adverse Drug Reactions Journal
关键词
立法
药物
法律实施
安全管理
药品管理法
Legislation, drug
Law enforcement
Safety management
Drug administration law
