摘要目的:分析2003年至2021年我国国家层面医疗卫生行业监管政策的演变，探讨不同阶段政策工具使用特点和规律，为政策优化提供参考。方法:以"医疗""监管"和"卫生""监管"为关键词，在国务院政策文件库中检索2003年至2021年中央政府层面发布的医疗卫生行业监管相关政策文件。基于"制定主体-执行主体-政策工具"分析框架，采用内容分析、社会网络分析和政策工具分析方法分析政策文件，对数据进行描述性分析。结果:共纳入236份政策文件。根据时间进展来看，2003年至2008年，共发文27份，制定主体以国务院为主(77.78%，21/27)，主要的执行主体为政府(100.00%，27/27)，使用政策工具191种，供给型、需求型和环境型政策工具的构成比分别为21.46%(41/191)、30.37%(58/191)和48.17%(92/191)。2009年至2017年，共发文48份，制定主体仍以国务院为主(93.75%，45/48)，执行主体仍以政府为主(100.00%，48/48)，但机构(25.00%，12/48)，行业组织(43.75%，21/48)和社会(37.50%，18/48)的占比有所提高，使用政策工具500种，供给型、需求型和环境型政策工具的构成比分别为17.40%(87/500)、32.00%(160/500)和50.60%(253/500)。2018年至2021年，共发文161份，制定主体以多部门为主(38.51%，62/161)，国务院的发文占比降至22.36%(36/161)，157份(97.52%)的执行主体为政府，使用政策工具1 140种，供给型、需求型和环境型政策工具占比分别为18.42%(210/1 140)、34.74%(396/1 140)和46.84%(534/1 140)。结论:2003年至2021年，我国医疗卫生行业监管领域政策的发文数量呈上升趋势，制定主体和执行主体呈现多样化，但不同类型的政策工具的使用存在不均衡问题。

abstractsObjective:To analyze the evolution of China′s national-level healthcare sector regulatory policies between 2003 and 2021, and explore the characteristics and patterns of the use of policy instruments at different stages, for references in policy optimization.Methods:The policy documents related to the regulation of the healthcare sector released by the central government were searched from 2003 to 2021 from the policy document database of the State Council using the keywords " medical" " regulation" and " health" " regulation". Based on the analysis framework of " formulation subject-implementation subject-policy tools", such methods as content analysis, social network analysis, and policy tool analysis were used to analyze policy documents and conduct descriptive analysis of data.Results:A total of 236 policies were included in the study.From 2003 to 2008, according to the time progression, a total of 27 documents were issued, with the State Council as the main formulation subject (77.78%, 21/27), and the government as the main implementation subject (100.00%, 27/27). 191 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments were 21.46% (41/191), 30.37% (58/191), and 48.17% (92/191). From 2009 to 2017, a total of 48 policies were issued, the formulation subject was mostly the State Council (93.75%, 45/48), and the implementation subject was still mostly the government (100.00%, 48/48), but the proportion of institutions (25.00%, 12/48), industry organizations (43.75%, 21/48) and the society (37.50%, 18/48) has increased. 500 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments were 17.40% (87/500), 32.00% (160/500), and 50.60% (253/500), respectively.From 2018 to 2021, a total of 161 documents were issued, with the formulation subjects featuring multiple subjects (38.51%, 62/161), with a decrease in the percentage of the State Council′s issuance (22.36%, 36/161), and 157 (97.52%) policies were implemented by the government. 1 140 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments being 18.42% (210/1 140), 34.74% (396/1 140), and 46.84% (534/1 140), respectively.Conclusions:From 2003 to 2021, there was an upward trend in the number of policies issued in the field of healthcare sector regulation in China, and the subjects of formulation and implementation were diversified. But the use of different types of policy instruments was uneven.