African Medicines Agency Has Key Role as Continent Pushes Local Vaccine Production Medicines & Vaccines 07/12/2021 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Dr Michel Sidibe, WHO’s Mariangela Simao and representatives from African medicine national regulatory authorities. The newly constituted African Medicines Agency (AMA) will be key in assisting the African Union (AU) to achieve its aim of producing 60% of vaccines on its own soil by 2040. This emerged at a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda this week. The PAVM was set up six months ago by the AU and Africa Centre for Disease Control and Prevention (CDC) to drive vaccine development. Major global pharmaceutical companies Pfizer, BioNTech, Moderna and Johnson and Johnson told delegates that vaccine manufacturing required long-term, capital intensive investment. But they also stressed the need for a harmonised regulatory environment to ensure the smooth and speedy assessment and registration of vaccines and medicines. That’s something that the AMA, could provide, once the agency is fully operational. The AMA Treaty formally came into force on 5 November after the AMA treaty was formally signed and ratified by 15 African countries. Altogether some 28 of Africa’s 55 countries have aligned with the treaty by signing and or ratifying it, as the continent ‘counts down’ to full buy-in from AU nations – with Uganda as the most recent country to ratify the treaty instrument. The Republic of #Uganda becomes the 18th member state to deposit the instrument of ratification of the African Medicines Agency (AMA). Congratulations The Treaty establishing AMA came into force on 5/11/2021 . @_AfricanUnion expects to have AMA operational in 2022 pic.twitter.com/ZtRQUH0oSV — Dorothy Njagi (@Dottienjagi) December 7, 2021 But major countries like South Africa, Nigeria and Kenya are among the 27 countries that have yet to sign. Differing skills Michel Sidibe, the AU Special Envoy for the AMA, said that the agency needed to “create a safe environment for investment”. “You will not attract investors if you have some countries with 40% of fake drugs or substandard drugs,” said Sidibe. “A harmonised regulatory system will help us to create a safe environment for investment from our own continent, and with partners who want to come and invest in our countries.” He added that “if we produce vaccines and drugs and we don’t have a mechanism on our continent to fast track the authorization process, it will not be helpful for our countries”. Country medicine regulators appeal for training While skills at the different country medicine regulators differ considerably, a panel featuring five national regulators, including South Africa, Morocco and Ethiopia, appealed for more support as the continent prepares to manufacture vaccines. Tumi Semete-Makokotlela, head of the South African Health Products Regulatory Authority (SAHPRA), said that harmonisation of processes across all 55 African states was important “so that we can rely on each other’s decisions”. She also appealed for investment in the regulators’ capabilities so that they could “do full lifecycle product management” from oversight of the clinical trials to product approval, pharmacovigilance and post-regulatory monitoring of products. Professor Bouchra Meddah, Director of Pharmacy and Medicines in Morocco’s Ministry of Health, also appealed to the Africa CDC, AMA and the World Health Organization (WHO) to provide technical assistance and staff training to all the regulators so that they were “all at a sufficient level in order to manufacture the vaccine”. Heran Gerba, Director-General of Ethiopia’s Food and Drug Authority, called for medical products’ approval processes to be expedited and efficient, adding that Ethiopia had an electronic regulatory information system for licencing, registration, pre-import permits and for imports, which had improved efficiency. The regulators have some experience in working together at the African Vaccines Regulatory Forum (AVAREF), which was set up in 2006 by the WHO to improve regulatory oversight of clinical trials conducted in Africa. AVAREF has also played an important role in accelerating the review of Ebola vaccines. AU Special Envoy for the AMA, Michel Sidibe WHO benchmarks The WHO benchmarks regulators and currently only two on the African continent – Ghana and Tanzania – have maturity level three, defined as a “stable, well-functioning and integrated regulatory system”. However, Dr Mariângela Simão, WHO Assistant Director-General or Drug Access, Vaccines and Pharmaceuticals, said 44 African countries had been assessed using the global benchmarking and “a few others are on a fast track to achieve maturity level three”. “Ideally, I would like to have at least half of the countries in five years times with maturity level three,” said Simao. Dr Margareth Ndomondo-Sigonda, Head of Health Programmes at the AU Development Agency, NEPAD, said the AU wanted to assist countries to get maturity level three primary through regional centres of excellence. These regional centres could, amongst other things, create legal frameworks to support harmonisation of vaccine manufacturing regulatory models; develop vaccine manufacturing knowledge; build leadership skills and develop sustainable financing mechanisms, she said. Sidibe urged that AMA “should become a reality quickly”. “We should do whatever we can to quicken the pace of implementation and operationalisation,” he stressed. “It will help us to tap into the African Free Trade Agreement”. The AMA treaty has been ratified and deposited by 18 African countries at present, with Uganda the most recent to have signed. See the interactive map here: AMA countdown map – multimedia Infogram An AU session early next year is to determine the seat of the new Agency. Meanwhile, the buy-in from other major AU nations, particularly South Africa and Kenya, as well as Nigeria, will be much-awaited milestones in the full operationalizing of the AMA vision. See more resources and details on the developing African Medicines Agency here on our Health Policy Watch ‘countdown’ site. Launching the ‘African Medicines Agency Countdown’ Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.