摘要
目的深入系统地分析我国药物研发与上市政策的现状和不足之处,为后续我国药物研发与上市政策的制定与完善提供参考意见。方法基于政策文本分析方法,选取2009-2022年国家层面发布的药物研发与上市政策文本为研究对象,对发文数量、发文主体、发文类型及“政策工具-研发上市阶段”分析框架4个维度进行定量分析。结果我国药物研发与上市政策数量呈阶段性增长;发文部门多以单独的形式发文,联合发文较少;文种类型丰富多样,多以通知、公告类型为主;政策工具以环境型为主(84.66%)、供给型工具次之(14.52%)、需求型最少(0.82%);药物研发上市过程发现阶段的政策工具使用很少(4.03%)。结论提出强化政府部门间的合作机制,增加意见、细则、工作程序等政策文本的发布,优化政策工具的内部结构,加大对需求型政策工具的使用,以及加大政策工具在药物发现阶段的使用的对策与建议。
Objective To analyze the current situation and shortcomings of Chinas drug research and development(R&D)and marketing policies,and to provide references for the subsequent formulation and improvement of Chinas drug R&D and marketing policies.Methods Based on the analysis of policy texts,drug R&D and marketing policies issued at the national level from 2009 to 2022 were selected as the research object,and were analyzed quantitatively on four dimensions:the number of texts,the subject of texts,the type of texts and the analysis framework of“policy tools-R&D and marketing stages”.Results The number of drug R&D and marketing policies in China showed phased increases;the issuing departments mostly issued texts in a separate form,but less in a joint form;the types of texts were rich and diverse,mostly in the form of notices and announcements;the policy tools were mainly environmental(84.66%),followed by supply-based tools(14.52%)and demand-based tools(0.82%);the use of policy tools during the discovery phase of drug R&D and marketing was rare(4.03%).Conclusion It is recommended to strengthen the cooperation mechanism among government departments,increase the publication of policy texts such as opinions,rules and working procedures,optimize the internal structure of policy tools,increase the use of demand-based policy tools,and increase the use of policy tools in the drug discovery stage.
作者
王欣
庄倩
WANG Xin;ZHUANG Qian(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211197,China)
出处
《广东药科大学学报》
CAS
2023年第4期7-13,共7页
Journal of Guangdong Pharmaceutical University
基金
国家自然科学基金青年科学基金项目(71602188)
江苏省高校哲学社会科学项目(2020SJA0086)。
关键词
药物研发与上市
文本分析
政策工具
drug research and development and marketing
text analysis
policy tools
作者简介
王欣,女,硕士研究生,Email:873774678@qq.com;通信作者:庄倩,女,博士,副教授,从事医药产业政策研究,Email:zhuang.cpu@163.com。
