Cecilia Mubambe/UNDP Zambia
Ensuring that people can access safe, effective and quality-assured medicines depends on strong and efficient regulatory systems. Across Africa, efforts are underway to strengthen and harmonize medical products regulation to support public health, facilitate local manufacturing and improve access to essential health technologies. Against this backdrop, regulators, policymakers and technical experts from across the continent gathered in Lusaka, Zambia, to advance a common regulatory framework that can help strengthen cooperation among African countries and accelerate access to medical products.
From 9-12 June 2026, the African Medicines Agency (AMA), in collaboration with the African Union Development Agency (AUDA-NEPAD) and the United Nations Development Programme (UNDP), convened a Regional Consultation on the Draft Model Regulations for the AU Model Law on Medical Products Regulation. The meeting brought together 31 participants from 18 African countries, including representatives from medicines regulatory authorities, ministries, regional organizations and technical partners.
The consultation formed part of ongoing efforts to support implementation of the AU Model Law on Medical Products Regulation and strengthen regulatory cooperation across the continent. As African countries continue to expand access to medicines, vaccines, diagnostics and other health technologies, effective regulatory systems play a critical role in ensuring that these products are safe and of assured quality.
Across Africa, regulatory frameworks have evolved at different rates, resulting in varying requirements and processes for approving and monitoring medical products. These differences can create challenges for regulatory authorities, manufacturers, and ultimately patients seeking timely access to essential health products. The draft model regulations seek to provide a common reference framework that countries can adapt to their national contexts while supporting greater consistency and collaboration across regulatory systems.
The stakeholder consultation provided an opportunity to review, refine and validate these critical model regulations. Through the Access and Delivery Partnership, UNDP has supported these efforts through a longstanding partnership with AUDA-NEPAD and the African Medicines Regulatory Harmonization (AMRH) initiative, and more recently through collaboration with the African Medicines Agency as it advances its mandate to coordinate and strengthen the regulation of medical products across the continent.
“The draft model regulations will serve as valuable tools for supporting regulatory harmonization across Africa,” said Alex Juma Ismail, Technical Lead, Product Evaluation & Scientific Opinions, AMA. “They will guide legislative and regulatory reforms in many Member States and contributed significantly to the objectives of the African Medicines Agency.”
Dr. Anthony Bakenga Kapeta, Legal Officer, AMRH Programme at AUDA-NEPAD, echoed this view, highlighting the strategic importance of the regulations. “The model regulations represent a critical step towards implementing the Revised African Union Model Law on Medical Products Regulation,” he said. “They provide a practical framework to support Member States in strengthening their regulatory systems and progressing towards WHO Maturity Level 3 (ML3).”
Over four days, participants reviewed the draft regulations governing the registration and authorization of medicinal products, drawing on experiences from their respective countries and institutions. Strong regulatory frameworks are essential not only for protecting public health, but also for enabling local pharmaceutical manufacturing, supporting medical innovation, strengthening preparedness for future health emergencies, and fostering greater confidence in health products circulating within and across borders.
“Africa is entering a new era of health innovation and pharmaceutical development,” said Dr. Saleban Omar, Programme Advisor, UNDP Zambia. “Strong, efficient and predictable regulatory systems will be critical to supporting local manufacturing, enabling innovation and ensuring that people across the continent can benefit from timely access to quality-assured medical product.”
By bringing together experts from across the continent, the consultation provided an opportunity to build consensus around shared priorities and advance a common vision for medicines regulation in Africa. The outcomes of the meeting will inform the continued refinement of the draft regulations as stakeholders work toward a framework that can support more efficient regulatory processes and deeper cooperation among Member States. UNDP remains committed to continuing its collaboration with AMA to promote regulatory harmonization and support equitable and timely access to quality-assured health products across the continent.