从《药品管理法》制修订解析我国药品监管理念变化趋势

doi:10.19803/j.1672-8629.2021.09.09

摘要/Abstract

摘要： 目的促进2019年《中华人民共和药品管理法》（简称“《药品管理法》”）贯彻执行。方法通过梳理我国《药品管理法》的3次制修订历程,比较其主要内容变化,解析我国药品监管理念的变化趋势。结果《药品管理法》的诞生及其修订历程,客观上反映了我国药品监管的历史背景及需求;历次修订内容的变化,反映了我国药品监管理念的变化及趋势。2019年修订的《药品管理法》进一步体现了“以人民为中心”、创新发展、与国际接轨、药品全生命周期管理、风险防控、科学监管及严格落实总书记“四个最严”要求等最新理念。结论深入理解我国药品监管的总体思路,对贯彻执行《药品管理法》、保护和促进公众健康具有重要意义。

关键词: 药品管理法, 制定, 修订, 药品监管, 理念, 变化趋势

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

中图分类号:

R951

夏东胜, 田春华, 王涛. 从《药品管理法》制修订解析我国药品监管理念变化趋势[J]. 中国药物警戒, 2021, 18(9): 837-844.

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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