Medicines Regulation in Africa: Current State and Opportunities

TLDR

Regulatory systems are essential for safeguarding public health by ensuring medical products meet international standards, yet African NMRAs vary in structure and function, with some embedded in ministries and others semi‑autonomous. The review aims to summarize the status of African NMRAs and assess initiatives, including the proposed African Medicines Agency, that could enhance their capacity. The authors conduct a narrative review of African NMRAs and related initiatives to evaluate their performance. Regulatory capacity in Africa has progressively improved, especially in quality control, post‑marketing surveillance, pharmacovigilance, and clinical trial oversight, aided by initiatives such as the African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories, and WHO Prequalification Scheme.

Abstract

Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous. There is progressive improvement in regulatory capacity, particularly in quality control and post-marketing surveillance, pharmacovigilance and clinical trials oversight. The African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories and WHO Prequalification Scheme have helped countries strengthen their regulatory capacities. The potential establishment of the African Medicines Agency (AMA) in 2018 is an opportunity to improve NMRAs' capacity in Africa.