Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency

Background: Key regulatory entities can serve as building blocks for the African Medicines Agency (AMA). The aim of this study is to demonstrate how the regional medicines regulatory harmonisation programmes could contribute to AMA's effectiveness and efficiency. Methods: A literature search was conducted using key words to identify publications about the AMA, African Medicines Regulatory Harmonisation (AMRH) and East African Community Medicines Regulatory Harmo-nisation programmes (EAC-MRH) from 2009 to 2023. The EAC-MRH programme experience was used to highlight the benefits and challenges of African regulatory harmonisation.Results: As the foundation for the AMA, the AMRH has established structures and workstreams to support its operationalisation, including 10 Technical Committees (TCs) and 5 Regional Economic Committees (RECs). Lessons learned from the EAC-MRH 10-year experience are being used to scale up regulatory harmonisation and could be of value to AMA harmonisation experience. Conclusions: As of June 2023, 35 of 55 countries have either signed and/or ratified the AMA Treaty, whilst 20 have neither signed nor ratified it. An effective AMA will need strong National Medicines Regulatory Authorities as well as Regional programmes and it is imperative for more well-resourced countries to ratify the treaty to ensure access to essential medical products and technologies for the African people.

Automated summary

The aim of this study is to demonstrate how regional medicines regulatory harmonisation programmes can contribute to the effectiveness and efficiency of the African Medicines Agency (AMA). The study highlights the establishment of structures and workstreams by the AMA, based on the experience of the East African Community Medicines Regulatory Harmonisation (EAC-MRH) programme. It emphasizes the importance of strong national regulatory authorities and regional programmes for the success of the AMA.