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ORIGINAL RESEARCH article
Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 |
doi: 10.3389/fmed.2024.1520892
This article is part of the Research Topic The Changing Focus of Regulatory Frameworks Around the Globe and the Opportunities for Harmonization View all 5 articles
Comparison of good review practices of seven countries participating in the ECOWAS Medicines Regulatory Harmonisation initiative: Identifying opportunities for improvement
Provisionally accepted- 1 Professor of Pharmacoepidemiology, University of Hertfordshire, Hatfield, United Kingdom
- 2 Food and Drugs Authority, Ghana, Cape Coast, Ghana
- 3 National Pharmaceutical Regulatory Agency, Ouagadougou, Burkina Faso
- 4 National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, Nigeria
- 5 Ministry of Public Health, Abidjan, Côte d'Ivoire
- 6 Ministry of Health and Social Action, Dakar, South Sudan
- 7 Pharmacy Board of Sierra Leone, Freetown, Sierra Leone
- 8 Directorate of Pharmacy, Medicine and Laboratories, Togo, Lome, Togo
- 9 School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herefordshire, United Kingdom
- 10 Centre for Innovation in Regulatory Science, London, England, United Kingdom
- 11 Institute for Medicines Development, Cardiff, United Kingdom
Introduction: When implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients' availability to safe, quality and efficacious innovative and generic products. It is important that all aspects of GRevPs are continuously evaluated and updated to promote the continuous improvement of regulatory systems at national and regional levels. The aim of this study was to assess and compare the GRevPs of the national medicines regulatory agencies (NMRAs) of Burkina Faso, Cote d'Ivoire, Ghana, Nigeria, Senegal, Sierra Leone and Togo, who are active participants of the ECOWASMRH initiative to identify opportunities for improvement.The Optimising Efficiencies in Regulatory Agencies questionnaire, was completed by each of the NMRAs, which facilitates the assessment of GRevPs, which in turn affect the regulatory review processes.: Except for Cote d'Ivoire and Nigeria which are autonomous, the other five NMRAs operate within the administrative structure of their respective Health Ministry, to regulate medical products for human use, medical devices and diagnostics. Apart from Togo, the agencies receive partial funding from their governments as well as from regulatory fees. Population in the seven countries ranges from 8.6 million to 211.4 million. All the NMRAs had measures in place to achieve quality in their review processes, although there were some remaining initiatives related to transparency and communication, continuous improvement and training and education, to be implemented. Of the ten quality decision-making practices Ghana had implemented nine into a framework, Togo eight, Cote d'Ivoire seven, Nigeria six, and Burkina Faso five; while Sierra Leone has partially implemented all ten and Senegal had not implemented any of the quality decision-making practices.The study compared the organisation, GRevPs and quality decisionmaking processes of the NMRAs that actively participate in the ECOWAS-MRH initiative. Though some differences were identified with regard to organisation, a significant number of good review practice initiatives and quality decision-making practices were identified yet to be implemented to promote continuous improvement in the regulatory processes of the NMRAs.
Keywords: Economic Community of West African States Medicines Regulatory Harmonisation (ECOWAS-MRH), good review practices, African Medicines Agency (AMA), regulatory reliance, Optimising Efficiencies in Regulatory Agencies (OpERA)
Received: 31 Oct 2024; Accepted: 23 Dec 2024.
Copyright: © 2024 Owusu-Asante, Darko, Seaneke, Nacoulma, Traore, Adeyeye, Akinyemi, Assane, Clamoungou, Ndao, Kande, Komeh, Mansaray, Lamboni, Agba, Walker and Salek. 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, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, AL10 9AB, Herefordshire, United Kingdom
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