Here's how the African Medicines Agency is coming together

People across the African continent eagerly await the launch of the African Medicines Agency, or AMA — an African Union regulatory health body tasked with the lofty goal of harmonizing regulatory processes across the continent. It’s an institution that is direly needed. Regulatory systems across the African continent are disjointed. That creates challenges for African pharmaceutical manufacturers that must register their products individually in each country rather than access the entire continent’s population through approvals at one Pan-African agency. The continent also struggles with substandard and falsified drugs, which need regulatory oversight to effectively weed out. And while the remit of AMA is massive and there’s a long road ahead, the work toward regulatory harmonization is ongoing in the lead up to the agency’s official launch, Chimwemwe Chamdimba told Devex on the sidelines of the Africa Centres for Disease Control and Prevention conference this week in Zambia. She heads the African Medicines Regulatory Harmonization program at the AU Development Agency. “It's not stop-start — it is a continuous process,” she said. And these efforts are actually over a decade in the making. In 2009, the African Union launched the African Medicines Regulatory Harmonization program, and in 2020 it launched its Smart Safety Surveillance program. The AMA treaty came into force in 2021 — and the new agency builds on both of these previous efforts. But there is a lengthy process in establishing the new agency. The AMA team is working to finalize its governing board, and after that, it can recruit a director-general, Chamdimba said. AMA already has a headquarters building in Rwanda, albeit not yet filled with staff, and it’s also piloting new continental procedures that are expected to change the game on how products are registered. This ongoing work is happening in technical committees that fall under the AMA umbrella, Chamdimba said. Some of these committees are old, and some were newly created for AMA, with the latest one expected to start its work in January. The existing committees include: • African vaccines regulatory forum: Provides oversight on clinical trials and joint reviews of complex products. • African medicines quality forum: Focuses on quality controls and market surveillance. • The African blood regulatory forum: Provides oversight on blood and blood product regulation. • The African medical devices forum: Provides oversight on medical devices and in vitro diagnostic regulation. • Good manufacturing practice: Focuses on the inspection of manufacturing sites. • Regulatory capacity development: Coordinates regional centers of regulatory excellence. • Medicines policy and regulatory reforms: Focuses on domestication of the AU Model Law on Medical Products Regulation. • Information management systems: Supports the operationalization of regulatory information management systems. The new committees include: • Evaluation of medicinal products: Supports joint reviews and marketing authorization. • Good manufacturing practice: Focuses on the inspection of manufacturing sites. • Pharmacovigilance and safety surveillance: Provides safety monitoring of medical products. Two of these new committees — the ones focused on the evaluation of medicinal products and good manufacturing practices — are about 1 year old and have already developed their own standards, guidelines, and processes, Chamdimba said. The one on pharmacovigilance and safety surveillance is set to launch soon. “We knew that the work of the African Medicines Agency requires them,” she said. One of these new committees is currently piloting out a continental procedure on the evaluation of medicinal products. In early November, it published a call for manufacturers planning to file an application for a new product to multiple national regulatory agencies in Africa — so that these manufacturers would instead apply through a continental process. Devex recently reported on a Kenya-based pharmaceutical company’s struggles for sustainability due to these disjointed markets. The managing director said it takes several years to register their products in each African country. He urged AMA to move quickly to create a process where products could be approved at a continental level, where countries could then approve the product within their borders if AMA signs off to ensure the product’s quality. The AU Development Agency said AMA’s initial efforts with piloting out a continental approach to evaluation of medical products are the start of efforts “poised to redefine the landscape of medicinal product evaluation in Africa.” The Pharmacovigilance and Safety Surveillance committee is slated to commence its work in January, Chamdimba said. Pharmacovigilance includes promoting the use of medicines in the way they were intended — for example, ensuring pharmacies aren’t handing out antibiotics without a prescription — a dangerous practice that can lead to pathogens developing resistance to these antibiotics. Another part of setting up AMA is putting its governance structures in place — but this three-tiered setup is still pending appointments. At the top is the Conference of State Parties, which includes ministers of health of the 27 countries that have ratified the AMA treaty, Chamdimba said. Ideally, all African countries would participate in AMA to ensure the maximum impact of the new agency. But each country must ratify the treaty on its own. The health ministers in the Conference of State Parties are tasked with charting the path forward on AMA’s strategic direction and also play a crucial role in ensuring there is political support in their own countries backing AMA — which will also help to ensure AMA is well resourced. Falling below these ministers is AMA’s governing board, which will report to the Conference of State Parties. But this board is not yet in place — the AMA team is still waiting on some nominations to fill the roles. “We have most of the nominations, and we are going to set it up as soon as we receive the final nominations that we are waiting for,” Chamdimba said. It’s a nine-member board that includes five heads of regulatory agencies from Africa’s five regions and an ethics expert, among others. The board will set up AMA’s policies, hire staff, and oversee AMA’s operations. “Once we have the board in place, then we’ll proceed with the recruitment processes of the director general,” Chamdimba said, adding that they have finalized the terms of reference for the director-general. The director-general will oversee the daily management of the institution, accompanied by a secretariat. The process of putting people in place has taken longer than some observers expected. For example, David Mukanga, deputy director of Africa Regulatory Systems at the Bill & Melinda Gates Foundation, wrote in May that he expected that the director-general would be appointed this year. The AU’s heads of state need to sign off on the nomination of the director-general — and leaders meet twice per year during the African Union summits in Addis Ababa. The next of these meetings is scheduled to take place in February, followed by a meeting in July. And while there have been calls for these processes to be hastened, others urge patience. “Establishing such a cross-jurisdictional structure as the AMA, responsible for common policies, practices and guidelines across the full range of healthcare commodities, is a massive undertaking, which must be allowed the requisite time to evolve and develop if it is to be successful and truly impactful in ensuring access to affordable, quality medicines for all Africans,” Iain Barton, founding principal at Health 4 Development, told Devex. But in the meantime, AMA’s office building in Rwanda stands waiting. “It is waiting for the staff,” Chamdimba said. “We hope that the staff will be available and to take up their position very soon.” Update, Dec. 6, 2023: This article has been updated with a new headline.