Broojerdi Alireza Khadem, Salvati Anna Laura, Abdelfattah Mohammed Refaat, Dehaghi Razieh Ostad Ali, Sillo Hiiti B, Gaspar Rogerio
Regulation and Prequalification Department, World Health Organization, Geneva, Switzerland.
Front Med (Lausanne). 2024 Sep 23;11:1467229. doi: 10.3389/fmed.2024.1467229. eCollection 2024.
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). 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.
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. 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. The framework was revealed to bring an evidence-based, inclusive, and transparent approach to recognizing 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. Furthermore, remarkable progress towards WLA listing was noted among transitional WLAs including the Stringent Regulatory Authorities (SRAs). Challenges related to the availability of resources, resistance to change, and complexity were associated with the framework.
The study provides a well-rounded view with regard to the roles of the WHO, Member States and other stakeholders in establishing and operationalizing the WLA framework. Furthermore, evaluating the performance and possible WLA designation of RAs operating at international regulatory standards underscores its high relevance in contributing to public health globally. Maintenance along with timely addressing of highlighted next steps to improve the framework particularly in creating better understanding, more communication, and coordination are highly encouraged.
在全球范围内增加获取安全、有效且质量有保证的医疗产品的机会，仍然是全面落实世界卫生大会关于加强医疗产品监管系统的第WHA 67.20号决议以及可持续发展目标（SDG）目标3.8的首要目标。为促进高效监管系统的发展，世界卫生组织于2016年推出了全球基准工具（GBT），随后建立了世界卫生组织认可机构（WLA）框架。本研究旨在评估WLA框架在各个阶段的发展情况，同时突出其成就、挑战和改进领域。
采用探索性研究设计，运用定性方法从相关文件以及来自不同背景的目标选定参与者的观点和经验中收集信息。通过案头审查以及使用带有开放式问题的半结构化访谈指南进行的深入一对一或小组访谈相结合的方式收集数据。采用归纳主题分析方法对数据进行分析。
注意到世界卫生组织在制定和实施重要文件以及在利益相关者之间调解协商过程中发挥的主导作用。该框架被揭示为采用基于证据、包容和透明的方法来认可以最高绩效标准运作的监管机构（RA）。预计该框架将促进所有监管机构、世界卫生组织的预认证计划和采购机构之间的监管互信。此外，在包括严格监管机构（SRA）在内的过渡性世界卫生组织认可机构中，在WLA列名方面取得了显著进展。与资源可用性、变革阻力和复杂性相关的挑战与该框架有关。
该研究全面审视了世界卫生组织、会员国和其他利益相关者在建立和实施WLA框架中的作用。此外，评估以国际监管标准运作的监管机构的绩效和可能的WLA指定，凸显了其在全球公共卫生贡献方面的高度相关性。强烈鼓励维持并及时处理为改进该框架而突出的后续步骤，特别是在增进理解、加强沟通和协调方面。
