By Baboloki Semele
Maputo, Mozambique – The 4th African Medicines Regulatory Harmonization (AMRH) Week, held in Maputo, Mozambique, from October 28 to November 1, 2024, gathered leaders in Africa’s pharmaceutical and medical regulatory sectors to renew efforts toward a unified, resilient regulatory framework across the continent. Hosted by AUDA-NEPAD and the World Health Organization (WHO), the event highlighted the importance of collaborative regulatory standards to advance the availability and quality of medical products.
Mozambique’s Health Minister, Dr. Armindo Tiago, praised the 15-year progress of the AMRH initiative and reiterated Mozambique’s commitment to achieving WHO’s Maturity Level 3 (ML3) for regulatory capacity, a milestone only six African countries have reached: Egypt, Ghana, Nigeria, South Africa, Tanzania, and Zimbabwe. ML3 certification signifies a regulatory system that is stable, well-integrated, and capable of ensuring quality healthcare products. Minister Tiago emphasized Mozambique’s determination to strengthen its regulatory capacity to align with the continent’s vision for a resilient health system.
Chimwemwe Chamdimba, head of the AMRH initiative at AUDA-NEPAD, reaffirmed the commitment of her team to supporting Mozambique and other African nations in building robust regulatory frameworks. Chamdimba noted that the AMRH initiative has significantly improved the efficiency of medicine approvals and fostered cooperative regulatory structures across member states. She added that AUDA-NEPAD’s initiatives have enhanced cross-border trust, helping nations without robust legal frameworks build regulatory capacity.
Reflecting on lessons from the COVID-19 pandemic, Dr. Rogerio Gaspar, WHO’s Director of Regulation and Pre-Qualification, underscored the urgency of establishing strong regulatory systems to prevent disparities in vaccine access, which led to over one million preventable deaths. He stressed that insufficient regulation can lead to fatal outcomes and urged African nations to reinforce their systems to better safeguard public health in future emergencies.
Dr. Abebe Genetu Bayith, coordinator of the Africa CDC’s health product manufacturing platform, pointed out that recent health crises highlight Africa’s need for greater self-sufficiency, especially in vaccine manufacturing. Bayith commended the AMRH’s foundational role in establishing the African Medicines Agency (AMA), which aims to facilitate the harmonization of medical regulation across Africa. As of June 2024, 29 countries have ratified the AMA Treaty, and the recruitment process for the agency’s first Director General is underway. AMA, headquartered in Kigali, Rwanda, is set to become the AU’s specialized agency for medical product regulation, incorporating roles from AMRH and the African Vaccines Regulatory Forum (AVAREF).
The AMA Treaty, adopted by the AU in February 2019 and activated in November 2021, represents a significant step in bolstering Africa’s medical production capacity and tackling issues like counterfeit and substandard products. Once operational, the AMA is expected to streamline the continent’s regulatory efforts, supporting a stronger, united approach to health security across Africa.
