15 Years of Advancing Medicine Regulation: Africa’s Path to Health Security

By Baboloki Semele

Maputo, Mozambique – The recently concluded 4th African Medicines Regulatory Harmonization (AMRH) Week marked a pivotal milestone in the ongoing journey toward stronger and unified medicine regulatory systems across Africa. Co-hosted by the African Union Development Agency (AUDA-NEPAD) and the World Health Organization (WHO), the event celebrated 15 years of initiatives aimed at harmonizing pharmaceutical regulations, bolstering health security, and preparing the continent for the future of medicine.

Themed “15 Years of African Medicines Regulatory Harmonization as a Foundation for Africa Medicines Agency-AMA,” the event brought together high-ranking officials, policymakers, members of AMRH Technical Committees, and various stakeholders, reflecting on the progress achieved in standardizing regulatory practices. These discussions highlighted the need for sustained efforts to address major challenges such as antimicrobial resistance (AMR), access to quality medicines, and the prevalence of falsified medical products.

Commemorated from 28th October 2024 to 01 November 2024, the 4th AMRH Week served not only to celebrate achievements but also to establish medium to long-term priorities for improving Africa’s regulatory landscape. Key events included sessions on Good Manufacturing Practices (GMP), Medicine Policy and Regulatory Reforms (MPRR), and the Annual Regional Centers of Regulatory Excellence (RCOREs) meeting. The highlight of the week was the African Medicines Regulators Conference (AMRC), where experts discussed strategies to harmonize standards and enhance partnerships across Africa.

The AMRH Initiative has made significant strides in recent years, according to Dr. Tumi Semete-Makokotlela, CEO of the South African Health Products Regulatory Authority (SAHPRA) and Chair of the AMRH Steering Committee. She praised the collaboration and commitment among National Regulatory Agencies (NRAs), which she believes have set a solid foundation for continued improvement. “This collaborative approach will enable us to achieve our shared vision of safe, reliable medicines across Africa,” Dr. Semete-Makokotlela remarked.

One of the key themes of AMRH Week was enhancing Africa’s capacity for local pharmaceutical production. Dr. Abebe Genetu, representing the Africa CDC, underscored the agency’s dedication to advancing vaccine manufacturing and strengthening regulatory systems. “Africa CDC is fully committed to supporting local manufacturing initiatives, which are essential for pandemic preparedness and resilience,” he stated. Dr. Genetu also discussed the development of a pooled procurement mechanism, expected to boost local production and create efficient, resilient supply chains.

Mr. Symerre Grey-Johnson, Director of Human Capital and Institutional Development at AUDA-NEPAD, highlighted AMRH’s success in reducing regulatory barriers and enhancing access to safe medical products. He noted significant achievements, including several NRAs reaching Maturity Level 3, which aligns Africa’s regulatory standards with global benchmarks. The launch of the Regulatory Information Sharing Portal (RISP) was also a major step forward, designed to foster collaboration among NRAs and facilitate rapid, unified responses to regulatory issues across the continent.

WHO’s Director of Regulation and Prequalification, Dr. Rogerio Gaspar, emphasized the need for robust systems to prevent the distribution of substandard and falsified products, especially in post-pandemic Africa. He called for enhanced regulatory vigilance and sustainable production practices to safeguard public health. “The AMRH Initiative has proven invaluable in building regulatory resilience, but we must remain focused on integrating new technologies and addressing emerging health threats, such as antimicrobial resistance,” Dr. Gaspar stated.

The AMRH Initiative’s 15-year journey has solidified Africa’s commitment to creating resilient, harmonized regulatory frameworks. Looking forward, the collaborative insights shared during the event will guide future efforts to ensure that safe, quality medicines are accessible to all African citizens. The foundation laid by the AMRH and the support for the African Medicines Agency reflect Africa’s dedication to health security and self-reliance.

As Africa continues to advance in medicine regulation, the partnerships and innovations fostered by AMRH Week will be crucial in transforming health systems and strengthening the continent’s role in global health standards.