| 唐菀晨,由玉伟,陆颖,顾淼.通过共建共治方式解决药品说明书信息公开、更新和应用问题研究[J].中国药事,2023,(8):890-896 |
| 通过共建共治方式解决药品说明书信息公开、更新和应用问题研究 |
| Study of Solving the Problems of Information Disclosure, Update and Application of Drug Labels by Constructing a Co-governance System |
| 投稿时间：2023-03-16 |
| DOI：10.16153/j.1002-7777.2023.08.005 |
| 中文关键词: 药品说明书 共建共治 信息公开 信息更新 信息化应用 |
| 英文关键词: drug label co-governance information disclosure information update information application |
| 基金项目:中国药品监督管理研究会“药品说明书共建共治体系研究”（编号 2022-Y-Y-006） |
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| 中文摘要: |
| 目的：通过构建药品说明书共建共治体系，以期解决我国药品说明书在信息公开、更新和应用中存在的问题。方法：以“药品说明书”等为关键词，通过检索万方数据知识服务平台、中国知网、欧洲药品管理局网站以及美国食品药品管理局网站，梳理国内外药品说明书信息公开和更新相关情况。通过实地调研与访谈、召开研讨会等方式，了解各相关方对于药品说明书的使用、公开意愿和信息化应用的需求，提出工作建议和信息化构想。结果与结论：随着药品审评审批制度改革深入开展，我国药品说明书信息公开、更新相关法律法规日趋完善，说明书内容不断规范，但目前仍存在上市许可持有人主体责任落实不够、信息不规范不共享以及信息化应用落后等问题。构建药品说明书共建共治体系可为解决相关问题提供新思路，药品监管部门可引导持有人落实主体责任，持有人应履行及时公开和更新药品说明书的责任，各方共同助力促进我国合理用药水平的提升。 |
| 英文摘要: |
| Objective: To solve the problems of information disclosure, update and application of drug labels by constructing a co-governance system in China. Methods: Through searching the keywords “drug label” on Wanfang data knowledge service platform, China National Knowledge Infrastructure, European Medicines Agency website and U.S. Food and Drug Administration website, the relevant situation of information disclosure, update and application of drug labels at home and abroad was sorted out. Through field research, interviews, seminars and other means, the study understood the use requirements, disclosure willingness and information application needs of drug labels of all relevant parties, so as to put forward work suggestions and information conceptions. Results and Conclusion: Because the reform of the drug evaluation and approval system was deepening and relevant laws and regulations on the disclosure and update of drug labels were improving these years, the drug labels were constantly standardized in China. However, there were still some problems such as the inadequate implementation of the marketing authorization holder’s (MAH’s) subject responsibility, non-standard and non-sharing of information, and poor application of information technology. Building a co-governance system of drug labels can provide ideas for solving related problems, and the drug regulatory departments could guide MAH implementing their subject responsibility. MAH could implement their subject responsibility of timely information disclosure and update of drug labels. All parties jointly help to enhance the level of rational and safe use of drugs in China. |
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