Alfonso Claudia P, N'Jambong Guy B, Magdy Alaa, Di Trapani Laura, Kuwana Rutendo, Kahsay Abraham G, Maïga Diadié, Ossei-Agyeman-Yeboah Sybil N A, Djitafo Fah Aimé B, Ndomondo-Sigonda Margareth
Regulatory Systems Strengthening, World Health Organization, Geneva, Switzerland.
Essential Drug and Medicines, World Health Organization, Dakar, Senegal.
Front Med (Lausanne). 2024 Apr 5;11:1362253. doi: 10.3389/fmed.2024.1362253. eCollection 2024.
Regulatory systems strengthening is crucial for catalyzing access to safe and effective medical products and health technologies (MPHT) for all. Identifying and addressing common regulatory gaps through regional approaches could be instrumental for the newly incepted African Medicine Agency.
This original study sheds light on common gaps among 10 national regulatory authorities (NRAs) and ways to address them regionally.
The study used NRA self-assessment outcomes to identify common gaps in four critical regulatory pillars and estimate the cost of addressing them from regional perspectives that aimed at raising the maturity level of regulatory institutions.
A cross-sectional study, using the WHO Global Benchmarking Tool (GBT), was conducted between 2020 and 2021 with five NRAs from ECCAS and ECOWAS member states that use French and Spanish as .
The 10 NRAs operated in a non-formal-to-reactive approach (ML1-2), which hinders their ability to ensure the quality of MPHT and respond appropriately to public health emergencies. Common gaps were identified in four critical regulatory pillars-good regulatory practices, preparedness for public health emergencies, quality management systems, and substandard and falsified medical products-with overall cost to address gaps estimated at US$3.3 million.
We elaborated a reproducible method to strengthen regulatory systems at a regional level to improve equitable access to assured-quality MPHT. Our bottom-up approach could be utilized by RECs to address common gaps through common efforts.
加强监管体系对于促进全民获得安全有效的医疗产品和卫生技术至关重要。通过区域方法识别并解决常见的监管差距，可能对新成立的非洲药品管理局有所帮助。
这项原创性研究揭示了10个国家监管机构（NRA）之间的常见差距以及区域层面解决这些差距的方法。
该研究利用NRA的自我评估结果，识别四个关键监管支柱中的常见差距，并从旨在提高监管机构成熟度的区域角度估计解决这些差距的成本。
2020年至2021年期间，采用世界卫生组织全球基准工具（GBT），对来自中非国家经济共同体和西非国家经济共同体成员国、以法语和西班牙语为官方语言的5个NRA开展了一项横断面研究。
10个NRA以非正规到被动反应的方式运作（成熟度水平1-2级），这阻碍了它们确保医疗产品和卫生技术质量以及对突发公共卫生事件做出适当反应的能力。在四个关键监管支柱——良好监管规范、突发公共卫生事件应对准备、质量管理体系以及不合格和假冒医疗产品方面，发现了常见差距，解决这些差距的总成本估计为330万美元。
我们阐述了一种可重复的方法，以在区域层面加强监管体系，改善公平获得有质量保证的医疗产品和卫生技术的机会。我们的自下而上方法可供区域经济共同体通过共同努力来解决常见差距。
