Changes of Drug Regulatory Concepts in Evidenced by Enactment and Revision of the Drug Administration Law

doi:10.19803/j.1672-8629.2021.09.09

Abstract

Abstract: Objective To boost the implementation of the Drug Administration Law. Methods The backgrounds and changes of the three versions of the Drug Administration Law during enactment and revision were analyzed and compared. Results The enactment and revision of the Drug Administration Law were true reflections of the historical background and demand of drug regulation in China. The changes of the contents in the three versions aligned with the changes of China's notions of drug regulation. The Drug Administration Law(2019) embodied the latest concepts, such as people-centeredness, innovation and development, alignment with international practice, drug lifecycle management, risk prevention and control, scientific supervision and strict implementation of the General Secretary's“four strictest”requirements. Conclusion A keen insight into the general idea of drug regulation in China is of great significance to the implementation of the Drug Administration Law and the protection and promotion of public health.

Key words: the Drug Administration Law, enactment, revision, drug regulatory, concept, developments

CLC Number:

R951

XIA Dongsheng, TIAN Chunhua, WANG Tao. Changes of Drug Regulatory Concepts in Evidenced by Enactment and Revision of the Drug Administration Law[J]. Chinese Journal of Pharmacovigilance, 2021, 18(9): 837-844.

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