Comparison of the review models and regulatory timelines of seven countries participating in the ECOWAS-MRH initiative: identifying opportunities for improvement

IntroductionNational regulatory medicines authorities (NRAs) are mandated to ensure timely access to high-quality, safe and efficacious medical products, primarily achieved through a marketing authorisation procedure established in each country. The aim of this study which was similar to that carrie...

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Autori principali:	Mercy Owusu-Asante, Delese Mimi Darko, Seth Seaneke, Aminata Nacoulma, Oula Ibrahim Olivier Traore, Mojisola Christianah Adeyeye, Abayomi Akinyemi, Coulibaly Assane, Clarisse Épse Kaul Meledje Clamoungou, Oumy Kalsoum Ndao, Rokhaya Ndiaye Kande, James Komeh, Sheku Mansaray, Dalkoi Lamboni, Maheza Agba, Sam Salek, Stuart Walker
Natura:	Artigo
Lingua:	Inglês
Pubblicazione:	Frontiers Media S.A. 2025-07-01
Serie:	Frontiers in Medicine
Soggetti:	African Medicines Agency (AMA) Economic Community of West African States Medicines Regulatory Harmonisation (ECOWAS-MRH) generics good review practices new active substances regulatory reliance
Accesso online:	https://www.frontiersin.org/articles/10.3389/fmed.2025.1587761/full
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