ORIGINAL RESEARCH article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1587761
Comparison of the review models and regulatory timelines of seven countries participating in the ECOWAS-MRH initiative: Identifying opportunities for improvement
Provisionally accepted
Mercy Owusu-Asante1,2Delese Mimi Darko2Seth Seaneke2Aminata Nacoulma3Oula Ibrahim Olivier Traore3Christianah Mojisola Adeyeye4Abayomi Akinyemi4Coulibaly Assane5Clarisse Epse Kaul Meledje Clamoungou5Oumy Kalsoum Ndao6Rokhaya Ndiaye Kande6James Komeh7Sheku Mansaray7Dalkoi Lamboni8Maheza Agba8
Sam Salek10,9*Stuart Walker1,11- 1School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, United Kingdom
- 2Food and Drugs Authority, Ghana, Accra, Ghana
- 3National Pharmaceutical Regulatory Agency, Ouagadougou, Burkina Faso
- 4National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, Nigeria
- 5Ministry of Public Health, Abidjan, Côte d'Ivoire
- 6Ministry of Health and Social Welfare, Republic of Senegal, Dakar, Senegal
- 7Pharmacy Board of Sierra Leone, Freetown, Sierra Leone
- 8Directorate of Pharmacy, Medicine and Laboratories, Togo, Lome, Togo
- 9Professor of Pharmacoepidemiology, University of Hertfordshire, Hatfield, United Kingdom
- 10Institute for Medicines Development, Cardiff, United Kingdom
- 11Centre for Innovation in Regulatory Science, London, England, United Kingdom
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Introduction: National 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 carried out in the SADC and EAC regions, was to assess and compare the review models and regulatory timelines good review practices of seven of the national medicines regulatory authorities (NRAs) of the Economic Community of West African States-Medicines
Keywords: African Medicines Agency (AMA), Economic Community of West African States Medicines Regulatory Harmonisation (ECOWAS-MRH), generics, good review practices, New active substances, regulatory reliance, Regulatory review models, key milestones
Received: 04 Mar 2025; Accepted: 11 Jun 2025.
Copyright: © 2025 Owusu-Asante, Darko, Seaneke, Nacoulma, Traore, Adeyeye, Akinyemi, Assane, Clamoungou, Ndao, Kande, Komeh, Mansaray, Lamboni, Agba, Salek and Walker. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Sam Salek, Professor of Pharmacoepidemiology, University of Hertfordshire, Hatfield, United Kingdom
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.