摘要
2023年是我国现代药品监管体制改革25周年。在过去25年里,我国药品监管体制在垂直管理和属地管理、机构独立和从属、职权统一和分散之间进行了4次反复,其原因是什么?通过系统分析4次药品监管体制改革的动因、过程和效果,发现国家对药品安全的自主追求导致了差异化改革路径。1998年,组建独立的国家药品监督管理局并实行药品监管省以下垂直管理,遵循了产业安全的逻辑。2003年,国家食品药品监督管理局挂牌成立。2008年,国家食品药品监督管理局调整为卫生部代管,省以下垂直管理改为地方政府分级管理,遵循了质量安全的逻辑。2013年,新建正部级国家食品药品监督管理总局,中央强调完善统一权威的药品安全监管机构,遵循了产业安全和质量安全的双重逻辑。2018年,党和国家机构改革充分考虑药品监管的特殊性,再次单独组建国家药品监督管理局,遵循了高质量发展的逻辑。总体来说,我国药品监管体制的结构是根据其所承载的功能而变迁的,当某种目标成为那个时代的主题时,药品监管体制就会发生相应的变化。具有自主性的党和国家,在“功能—结构”互动中扮演主要角色,推动了这一波澜壮阔的历史进程。
2023 marks the 25th anniversary of China's modern drug regulatory system reform.In the past 25 years,the drug regulatory system has carried out four iterations between vertical administration and dependency administration,independent and subordinate institutions,and unification and decentralization of functions and powers.What is the reason?Through the systematic analysis of the motivation,process and effect of the four drug regulatory system reforms,it was found that the independent pursuit of drug safety led to the differentiated reform path.In 1998,an independent State Drug Administration(SDA)was established,and drug supervision was put into place under province vertical management,in accordance with the principles of industrial safety.In 2003,the State Food and Drug Administration(SFDA)was established.Following the logic of quality safety,the SFDA which was overseen by the Ministry of Health,altered its vertical management from provincial to local level management in 2008.Following the dual logic of industrial safety and quality safety,China Food and Drug Administration(CFDA)was founded at the ministerial level in 2013,and the central government stressed the perfection of a unified and authoritative drug safety regulatory organization.In 2018,the Party and state institutions fully considered the uniqueness of drug regulation and once again established National Medical Products Administration(NMPA)on the basis of drug safety.Overall,the structure of China's drug regulatory system has changed along with the functions it carries.When a specific goal becomes the theme of that era,the drug regulatory system will change accordingly.This dramatic historical process is driven by this autonomous party and state,which serve as significant players in the"function-structure"interaction.
作者
胡颖廉
HU Ying-lian(Department of Social&Ecological Studies,China Central Party School(Chinese Academy of Governance))
出处
《中国食品药品监管》
2023年第3期4-15,共12页
China Food & Drug Administration Magazine
