Plans to establish the African Medicines Agency (AMA), responsible for overseeing regulatory processes for pharmaceutical products throughout Africa, are progressing, according to official sources. As of now, 35 out of the African Union’s 55 member states have ratified the AMA Treaty. The recent inclusion of countries like Kenya, Malawi, and Sao Tome bolsters local pharmaceutical production efforts, aligning with the call for a unified One Health approach to disease control in Africa.

Chimwemwe Chamdimba, head of health at the AU Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), disclosed that the agency’s bureau is already operational, and the governing board is taking shape. The AMA, as a specialized health agency of the AU, aims to harmonize medicine regulations across Africa. Member states are expected to finalize the formation of the governing board in the coming months, thereby replacing the need for manufacturers to seek approval from each fragmented regulatory authority of the 55 member states or the five regional economic communities.

The harmonization efforts of the AMA will not only address fragmentation but also facilitate collaboration among the five African regions. 

It will enable joint assessments and inspections by national regulators, fostering trust and cooperation within the regional economic communities. The AU is collaborating with partners like Amref Health Africa to train national regulators, and a continental regulatory reliance framework is being developed, with pilot implementation planned for the East Africa region.

The establishment of the AMA holds significant importance due to the challenges associated with accessing safe, affordable, effective, and quality medicines in Africa. Factors such as limited pharmaceutical industries, high costs of raw materials, inadequate investment in research and development, and reliance on foreign countries for medicines contribute to the complexities. Poor supply chains, insufficient government investment in the pharmaceutical sector, limited health workforce, and lack of infrastructure and technical expertise exacerbate the situation, leading to the circulation of counterfeit drugs causing numerous deaths each year.

Experts and academics in the health sector have widely welcomed the initiative, recognizing its potential to ensure access to safe and effective medicines for Africans. The inclusion of access to affordable and safe medicines as a fundamental human right in the UN-mandated Sustainable Development Goals further emphasizes its significance. The establishment of the AMA is seen as a crucial step towards achieving Universal Health Coverage and bridging the gap in healthcare access across the continent.

Michel Sidibé, the AU’s special envoy for AMA, applauded the agency’s formation, emphasizing its potential to encourage local development and manufacturing of medicines, reducing dependence on imports. Sidibé, a former minister of health and social affairs in Mali and former executive director of UNAIDS, highlighted how the COVID-19 pandemic exposed vulnerabilities and stressed the importance of regulatory harmonization in Africa.

Rwanda has been selected as the host country for the AMA headquarters. The agency’s establishment will complement the efforts of the Africa Centres for Disease Control and Prevention (Africa CDC), particularly in pandemic preparedness. It will enhance the continent’s readiness for future pandemics and support post-pandemic recovery. The AMA, as Africa’s second-largest health agency following Africa CDC, is expected to play a vital role in fostering the continent’s ambitions for drug and vaccine production.