Saba Berhane
Manager, Regulatory Affairs, IFPMA
Regulatory alignment across Africa can boost life sciences innovation, aiding pharmaceutical sector growth and enhancing patient access to medicines and vaccines.
For over a decade, significant progress has been made in strengthening Africa’s regulatory ecosystem, led by initiatives such as the Africa Medicines Regulatory Harmonization (AMRH), World Health Organization and the African Union Development Agency-NEPAD, paving the way for the African Medicines Agency (AMA).
Enabling efficient regulatory collaboration
Through the development of common standards and regulations, this Agency could become one of the most efficient and modern regulatory systems in the world.
Its successful operationalisation would enable collaboration between national regulatory authorities, work-sharing and reliance procedures and mutual recognition of regulatory decisions. This would build regulatory capability and capacity, streamline processes and ultimately lead to timelier access to medicines and vaccines for African patients. It envisions a continent-wide regulatory environment on the continent.
This Agency could become one of
the most efficient and modern
regulatory systems in the world.
Supporting a strong ecosystem
In particular, the AMRH continental technical committees have made tremendous efforts and progress to support its establishment. This includes the revision of the AU Model Law on Medical Products Regulation, the development of continental guidelines and procedures for the listing of medical products and the establishment of a continental infrastructure management system for the exchange of regulatory information.
The pharmaceutical industry is contributing technical expertise and experience with global regulatory standards while volunteering in regional pilot projects to optimise and shape new processes.
Transformed regulatory environment
This is pivotal for the healthcare landscape in Africa. An operational AMA, alongside a strengthened health workforce, will not replace regional and national regulatory authorities but leverage these to support a cohesive continental body. This will improve health outcomes in Africa and combat falsified and substandard medicines across the continent’s health systems.
Amid digital transformation, these innovations also contribute to revolutionising regulatory processes, thus enhancing efficiency and sustainability. Progress made to operationalise the AMA so far must be commended, particularly the announcement of a Board in April. The critical next step is the appointment of its Director-General. Under their leadership, we can build on the foundations of the AMA and enable an African regulatory environment that benefits all patients.
