Senegal makes history by leading regulatory development in Francophone Africa

Senegal recently became the 7th country on the African continent to achieve World Health Organisation (WHO) Maturity level 3 (ML3) for medicines regulation (non-producing) on the WHO Global Benchmarking and the first francophone African countries to attain this recognition by the WHO. Attaining ML3 reflects a stable and well-functioning regulatory system, capable of critical functions such as rapid product authorization, market surveillance, and adverse event monitoring. This is a significant milestone for the country's healthcare system and pharmaceutical sectors, for francophone Africa and for regulatory development on the continent of Africa.

Senegal's medicines regulator, the Agence sénégalaise de Réglementation pharmaceutique (ARP) reached this level following a rigorous benchmarking process conducted by WHO. It has made history by becoming the first francophone African country to achieve ML3 status. ARP's maturation highlights Senegal's commitment to ensuring the safety, efficacy, and quality of medical products for its population.

Senegal’s progress aligns with the growing momentum towards continent-wide regulatory harmonisation and the operationalization of the African Medicines Agency (AMA). It demonstrates Senegal's readiness to play a central role in strengthening Africa’s pharmaceutical ecosystem as a leader in francophone Africa. It is the 7th country of eight regulatory authorities on the continent who have achieved this milestone - that is South Africa, Zimbabwe, Ghana, Nigeria, Tanzania, Egypt with Rwanda, the host of the African Medicines Agency being the 8th. This milestone is a testament to Senegal's robust regulatory framework. It also positions the country as a leader in the African continent, particularly in Francophone Africa. This recognition positions it as an important player in the development and regulation of vaccines and other medical products.

With its success, Senegal becomes a model for other Francophone nations of Africa. It also enhances its influence within the region and strengthens its ability to attract investment and collaboration in vaccine development and production. Senegal is already a key player in vaccine production in Africa. It is one of the few countries globally manufacturing yellow fever vaccines at the Institut Pasteur de Dakar (IPD). This renowned institute has been instrumental in supplying life-saving vaccines to Africa and beyond. This showcases Senegal's capacity for high-quality vaccine production. With the country's recent achievement of WHO Maturity Level 3 in medicines regulation, Senegal is poised to expand its role as a leader in vaccine innovation and development, further strengthening its impact on public health in the region and the world.

The achievement further contributes to Africa’s collective goal of building resilient health systems by increasing the level of medical products manufactured on the African continent as a sustainable pathway to improving access to safe, high-quality medical products. By reaching this benchmark, Senegal has laid the groundwork for qualifying as a WHO-listed Authority, a distinction that would raise its credibility on the global stage and catalyze its aspirations to become a regional hub for vaccine innovation and development.

Senegal is now set to lead the way in making the people of Africa healthier by leveraging its regulatory strength to ensure sustainable development of the health pharmaceutical sectors on the continent. Senegal could further contribute to regulatory development by making the report of its benchmarking assessment public available for other African countries to learn from. So far, out of the eight African medicines regulatory authorities that has attained level 3 maturity, inly Zimbabwe has made its report publicly available. Having more countries making their own reports public would highlight their role as leaders and their commitment to catalysing regulatory harmonisation on the African continent. AS Senegal takes it rightful place as a leader in Africa's regulatory development, will it also make the commitment to catalyze regulatory harmonisation? Time will tell.