A key milestone for medicines regulation in Africa has been reached with the first continental listing of five medicinal products by the African Medicines Regulatory Harmonisation (AMRH) Steering Committee.
The listing follows successful assessment for quality, safety and efficacy by the Evaluation of Medicinal Products Technical Committee (EMP-TC) in collaboration with the Good Manufacturing Practices Technical Committee (GMP-TC), marking a major step forward in ensuring African patients have faster access to high-quality medicines.
The continental procedure pilot directly addresses issues of fragmented regulatory systems, lengthy approval processes and limited capacity for rigorous product assessments by streamlining approvals, fostering reliance among African Union (AU) member states and supporting the operationalisation of the African Medicines Agency (AMA).
Technical support for the pilot has been provided by the European Medicines Agency (EMA), the World Health Organization (WHO) and other partners. The EMA has also collaborated by leveraging its experience in coordinating regulatory systems through its well-established technical committee model.
Ms Chimwemwe Chamdimba, Head of the AMRH programme, remarked:
‘Beyond strengthening health systems for Africa, this achievement signals a turning point for Africa’s pharmaceutical industry, creating an environment that fosters innovation, attracts investment, and accelerates regional trade in medicines. A harmonised regulatory approach streamlines processes for pharmaceutical manufacturers, enabling them to scale production and expand market access across the continent. This is a critical step in positioning Africa as a leader in pharmaceutical manufacturing, fully aligned with the African Union’s industrialisation and trade goals.’
Congratulating the AMRH on the milestone event, EMA Head of International Affairs, Martin Harvey, commented:
‘It is truly thrilling to see these first outcomes of the continental joint assessment and GMP inspections. EMA has accompanied our African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD) colleagues along this journey, sharing our own experience of successfully bringing together experts from different countries. The success of the AMA will depend on strong regional and national systems. Today is a historic milestone, and I look forward to a long and successful relationship between our two sister agencies, the AMA and EMA.’
The EMP-TC has published a ‘Green Book’ registry of continentally listed products, which will be updated as more products are listed.
