Zambia and Nigeria take bold steps toward strengthening health products regulation in Africa
PATH commends Zambia and Nigeria for their leadership in ratifying the African Medicines Agency (AMA) Treaty, marking a pivotal step toward strengthening regulatory systems across Africa. This brings up to 30 out of 55 African Union (AU) member states who have ratified AMA. By ratifying and operationalizing AMA, African countries are laying the foundation for a more harmonized, efficient, and responsive regulatory landscape. As more countries commit to this initiative, the continent moves closer to ensuring widespread access to safe, effective, high-quality medicines.
AMA streamlines medicine regulation across Africa by working closely with national regulators, who play a crucial role in fast-tracking approvals, preventing substandard drugs, and supporting pharmaceutical growth. Since 2019, AMA has gained momentum, with countries contributing to governance, adopting joint regulations, and strengthening safety monitoring, data-sharing, and capacity-building. Sustainable funding from member countries remains key to its success.
“Nigeria and Zambia’s ratification of the AMA highlights the power of collaboration and collective efforts between governments, regional agencies and partners to enhance regulatory excellence.”— Rachel Ndirangu, Regional Director, Advocacy & Public Policy-PATH
At PATH, we remain committed to supporting AMA ratification across Africa, working to ensure that every person can trust the safety and quality of the medicines and medical products they depend on. PATH and its partners work together to support the vision of AMA by working with AU, regional economic blocs, governments, and other stakeholders, aiming to strengthen regulatory systems and ensure access to quality medicines.
PATH, in partnership with the Africa Union Development Agency (AUDA-NEPAD, the development agency of the AU, has been actively working with governments to facilitate the ratification process. This includes developing legal and technical guidance, increasing awareness of AMA’s benefits, and engaging policymakers, civil society, and health experts to ensure broad support. In 2024, PATH worked with AUDA-NEPAD to develop the Ratifying the African Medicines Agency Treaty Tool Kit. It held a Capacity-Building Workshop on the African Medicines Regulatory Harmonisation (AMRH) initiative, the AMA Treaty, and the AU Model Law on Medical Products Regulation in Rwanda.
For AMA’s long-term success, it is crucial that governments fully implement the treaty by adopting domestic laws, investing in regulatory capacity, and fostering cross-country collaboration. Equally important is the continued technical and financial support from partners. Strengthening regulatory systems is not just about compliance—it's about protecting lives and ensuring health equity across Africa. This is a shared responsibility that we all must actively engage in.