The African Medicines Regulatory Harmonization Initiative: Progress to Date

TLDR

The African Medicines Regulatory Harmonization Initiative has shortened marketing authorization timelines in East and Southern African member states, but challenges remain in leveraging joint dossier reviews for national decisions, and biennial conferences serve as a platform for stakeholder knowledge exchange. The initiative aims to establish the African Medicines Agency to eliminate technical trade barriers and advance continental socio‑economic development. The strategy includes establishing eleven regional regulatory excellence centers for training and workforce growth, and aligning multiple regional forums—vaccines, laboratories, devices, diagnostics, and blood—to lay the groundwork for the African Medicines Agency. Twelve countries have adopted the African Union Model Law on Medical Products Regulation, creating a foundation for strengthening regulatory systems.

Abstract

The African Medicines Regulatory Harmonization Initiative (AMRH) has contributed to reduce marketing authorization timelines in East African Community and the Southern African Development Community member states. Challenges still exist in using the outcome of the regional joint dossier review processes for national decision making processes by the national medicines regulatory agencies. Progress in domestication of the African Union Model Law on Medical Products Regulation by twelve countries provides basis for improving regulatory systems. This is coupled by the designation of eleven regional centers of regulatory excellence which will ensure sustainable training programmes and subsequent increase in Africa's regulatory workforce. The Biennial Scientific Conferences on Medical Products Regulation in Africa is a strategic platform for knowledge and ideas exchange among key stakeholders in the pharmaceutical sector. The ongoing alignment of the African Vaccines Regulators Forum, the Network of Medicines Control Laboratories in Sub-Saharan Africa, Pan African Harmonization Working Party on the regulation of medical devices and diagnostics, the planned establishment of a forum for blood and blood with AMRH serves as a solid foundation for establishment of the African Medicines Agency (AMA). AMA will be a key driver to remove technical barriers for trading among the region countries by contributing to the continental socio-economic development agenda.