PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: This original study sheds light on common gaps among 10 national regulatory authorities (NRAs) and ways to address them regionally.
UNASSIGNED: 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.
UNASSIGNED: 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 lingua franca.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: This original study sheds light on common gaps among 10 national regulatory authorities (NRAs) and ways to address them regionally.
UNASSIGNED: 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.
UNASSIGNED: 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 lingua franca.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■加强监管体系对于促进所有人获得安全有效的医疗产品和卫生技术（MPHT）至关重要。通过区域方法确定和解决共同的监管差距可能对新成立的非洲医药机构有所帮助。
■这项原始研究揭示了10个国家监管机构（NRA）之间的共同差距以及解决这些问题的方法。
■该研究使用NRA自我评估结果来确定四个关键监管支柱中的共同差距，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。
■一项横断面研究，使用世卫组织全球基准测试工具(GBT)，在2020年至2021年之间与来自中非经共体和西非经共体成员国的五个NRA进行了合作，这些NRA使用法语和西班牙语作为通用语。
■10个NRA以非形式到反应的方式（ML1-2）进行操作，这阻碍了他们确保MPHT质量和适当应对突发公共卫生事件的能力。在四个关键监管支柱——良好监管做法、为突发公共卫生事件做好准备，质量管理体系,以及不合格和伪造的医疗产品-解决差距的总成本估计为330万美元。
■我们制定了一种可重复的方法，以加强区域一级的监管系统，以改善公平获得有保证质量的MPHT的机会。区域经济共同体可以利用我们自下而上的方法，通过共同努力解决共同的差距。
■这项原始研究揭示了10个国家监管机构（NRA）之间的共同差距以及解决这些问题的方法。
■该研究使用NRA自我评估结果来确定四个关键监管支柱中的共同差距，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。
■一项横断面研究，使用世卫组织全球基准测试工具(GBT)，在2020年至2021年之间与来自中非经共体和西非经共体成员国的五个NRA进行了合作，这些NRA使用法语和西班牙语作为通用语。
■10个NRA以非形式到反应的方式（ML1-2）进行操作，这阻碍了他们确保MPHT质量和适当应对突发公共卫生事件的能力。在四个关键监管支柱——良好监管做法、为突发公共卫生事件做好准备，质量管理体系,以及不合格和伪造的医疗产品-解决差距的总成本估计为330万美元。
■我们制定了一种可重复的方法，以加强区域一级的监管系统，以改善公平获得有保证质量的MPHT的机会。区域经济共同体可以利用我们自下而上的方法，通过共同努力解决共同的差距。
