DOI

10.5703/1288284317443

Tech Report Number

TR-BIRSAFRICA-2021-11

Date of this Version

12-9-2021

Keywords

Medicines, regulation, marketing authorization, Good Manufacturing Practice (GMP), National Medicines Regulatory Authorities (NMRAs); Economic Community of West African States (ECOWAS), West African Health Organization (WAHO), West African Medicines Regulatory Harmonization (WA-MRH)

Abstract

Ndomondo-Sigonda et al. (2017) observed that there is scarcity of information on human resources (person-nel devoted to regulation of medicines) in the domain of medicines regulation in the sub-Saharan Africa (SSA). The published information on medicines regulation by the National Medicines Regulatory Authorities (NMRAs) in the Economic Community of West African States (ECOWAS) region are no longer current and consistent with the current realities in the NMRAs. In order to reveal this occurrence, show the trends that exist over the years and make appropriate recommendations, data were collected and compared from 2005, 2010 and 2017 research reports on seven regulatory features of the fifteen Members States of ECOWAS. The re-sults show that there was missing information per regulatory feature and country. There was also an overall increasing trend in the number of NMRAs in the region that showed progress with respect to the measured regulatory features - Autonomy (Authority and Legal form), Marketing Authorization), GMP inspection, Quality Control, Quality Management System, Information Management System and Harmonization and International cooperation. People of Africa have a valuable story to tell as it relates to medicines regulation. This report is written by a West African from the perspective of a West African involved in the study and practice of medi-cines regulation by the NMRAs in the ECOWAS.

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