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

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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Main Authors: 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
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-07-01
Series:Frontiers in Medicine
Subjects:
African Medicines Agency (AMA)
Economic Community of West African States Medicines Regulatory Harmonisation (ECOWAS-MRH)
generics
good review practices
new active substances
regulatory reliance
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2025.1587761/full
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