Raffaella’s Literature Update
Ref. Alfonso CP, N’Jambong GB, Magdy A, Di Trapani L, Kuwana R, Kahsay AG, Maïga D, Ossei-Agyeman-Yeboah SNA, Djitafo Fah AB, Ndomondo-Sigonda M. Identifying and costing common gaps in Central and West Africa pharmaceutical regulation. Front Med (Lausanne). 2024 Apr 5;11:1362253.
Dear Friends,
Those interested in the upgrade of capacities of national regulatory authorities (NRAs), will read with interest this manuscript, which has focus on Central and West Africa. Alfonso and colleagues used NRAs’ outcomes from the self-assessment conducted with the WHO Global Benchmarking Tool (GBT) in 2020 and 2021, to identify common gaps in four critical regulatory pillars, and to estimate the cost of addressing them. The 10 NRAs operated in a non-formal-to-reactive approach, which corresponds to a regulatory maturity level 1-2, as per WHO GBT. This level is insufficient to ensure the quality of medical products and health technologies and to 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 (the capacity to prevent, detect, and respond to) substandard and falsified medical products. The authors estimate the overall cost to address these gaps at US$3.3 million. By the way, the up-to-date List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4) can be consulted here: List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4) (who.int).
I also take this opportunity to share also the most recent version of our informal Quality Fact Sheet.
Very best,
Raffaella