dminister drugs according to law to ensure the medication safety of the public: an analysis on the key points in the revision of the Drug Administration Law of the People′s Republic of China
The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing 211198, China
Abstract：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.
邵蓉, 陶田甜. 依法治药，保障公众用药安全：《中华人民共和国药品管理法》修订要点解析[J]. 药物不良反应杂志, 2019, 21(5): 377-380.
Shao Rong, Tao Tiantian. dminister drugs according to law to ensure the medication safety of the public: an analysis on the key points in the revision of the Drug Administration Law of the People′s Republic of China. Adverse Drug Reactions Journal, 2019, 21(5): 377-380.
