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世界卫生组织协助的当局(WLA)框架:促进监管依赖增加获得质量保证医疗产品的透明证据方法

WHO-Listed Authorities (WLA) framework: Transparent Evidence-based Approach for Promoting Regulatory Reliance towards Increased Access to Quality-assured Medical Products

Frontiers in Oncology 等信源发布 2024-09-05 08:09

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register hereBackground: Increased global access to safe, effective and quality-assured medical products remains a primary goal for the full realization of the World Health Assembly Resolution WHA 67.20 on regulatory systems strengthening for medical products as well as target 3.8 of the Sustainable Development Goals (SDG).

注册背景:增加全球获得安全、有效和有质量保证的医疗产品的机会仍然是全面实现世界卫生大会关于加强医疗产品监管体系的WHA 67.20号决议以及可持续发展目标(SDG)目标3.8的主要目标。

To promote the development of efficient regulatory systems, the WHO introduced the Global Benchmarking Tool (GBT) in 2016, upon which the WHO-Listed Authority (WLA) framework was later established. This study aimed to appraise the development of the WLA framework across various phases while highlighting its achievements, challenges, and areas for improvement.Methods: An exploratory study design using a qualitative approach was used to gather information from relevant documents as well as views and experiences from purposefully selected participants from diverse backgrounds.

为了促进高效监管体系的发展,世卫组织于2016年引入了全球基准管理工具(GBT),随后建立了世卫组织上市管理局(WLA)框架。这项研究旨在评估WLA框架在各个阶段的发展,同时强调其成就,挑战和改进领域。方法:使用定性方法的探索性研究设计,从相关文件中收集信息,以及来自不同背景的有目的选择的参与者的观点和经验。

Data was collected using a combination of desk reviews and In-depth one-to-one or small group interviews employing semi-structured interview guides with open-ended questions. Data was analysed using an inductive thematic analysis approach.The leading role of the WHO was noted in developing and implementing essential documents and mediating consultative processes among stakeholders.

数据收集采用案头审查和深度一对一或小组访谈相结合,采用半结构化访谈指南和开放式问题。。人们注意到世卫组织在制定和实施基本文件以及调解利益攸关方之间的协商进程方面发挥的主导作用。

The framework was revealed to bring an evidence-based, inclusive, and transparent approach to recognising regulatory authorities (RAs) operating at the highest standards of performance. The framework was anticipated to promote regulatory reliance among all RAs, the WHO's prequalification programme, and procurement agencies.

该框架揭示了一种基于证据、包容性和透明的方法,以认可以最高绩效标准运作的监管机构(RAs)。预计该框架将促进所有RA、世卫组织资格预审计划和采购机构之间的监管依赖。

Furthermore, remarkable progress towards WLA listing was noted among transitional WLAs including the Stringent Regulatory Authorities (SRAs).Challenges related to the availab.

此外,包括严格监管机构(SRA)在内的过渡WLA在WLA上市方面取得了显着进展。与availab相关的挑战。