African Medicines Agency (AMA)

ince the minimum number of 15 ratifications by African Union (AU) countries was reached to establish the AMA in November 2021, the AU has stepped up efforts, through the African Union Commission and the African Union Development Agency, to prepare for the opening of the AMA Secretariat. They have developed a joint workplan, with elements including a continued push for further ratification by additional countries, developing an AMA roadmap for the first year and subsequent years, setting up AMA’s core activities and detailed procedures, and developing AMA business processes (including enterprise resource planning). They also agreed on the division of labor between their respective organizations and have started to engage with multiple partners around this workplan, including the European Medicines Agency (EMA), national regulators in Europe and elsewhere, and funding partners, among others, to explore how they can leverage others’ experiences in support of setting up the AMA. Formal assessment of the eight host country candidates has been completed, and the Executive Council of the AU will meet in July 2022 to decide on this host.

Partnerships for African Vaccine Manufacturing (PAVM)

The Africa Centers for Disease Control and Prevention (Africa CDC) and African Union Development Agency (AUDA-NEPAD) have established a regulatory workstream to prepare regulatory capacity to oversee vaccine manufacturing within several African countries aspiring to start or to grow their vaccine manufacturing capacity.

Enabling African national regulatory agencies (NRAs) in these countries to achieve WHO certification for maturity level 3 (ML3, a stable, well-functioning, and integrated regulatory system) is essential for these manufacturing efforts to be successful. Without this WHO certification, these vaccines will not be eligible for WHO prequalification and will in turn be locked out of the United Nations/GAVI/COVAX market that supplies the largest share of vaccines consumed on the African continent.

NRAs achieving ML3 status is also important for AMA, as these countries with a high level of regulatory performance can offer this expertise to AMA. AMA will rely on the expertise and resources of NRAs when undertaking its procedures. To date, four national agencies have attained WHO ML3 certification (Ghana, Nigeria, and Tanzania for medicines and imported vaccines, and Egypt for vaccine production). South Africa has been assessed for WHO certification, and some sources indicate they are very close to achieving ML3 (vaccine-producing) status.

Finally, NRAs in the African countries aspiring to manufacture vaccines are also discussing how to best collaborate and rely on one another, especially in lot testing and release. These countries recognize that it will be cost prohibitive for each to try to set up its own full range capacity for all the vaccines produced within its territory, in addition to maintaining that capacity and competency over time. The idea of an African laboratory network for lot release has been introduced in these conversations. The success of this idea will go a long way toward positioning Africa as a common, well-coordinated regulatory network and a common market of 1.2 billion people, in congruence with the African Continental Free Trade Area.