The Pharmaceutical Manufacturing Plan for Africa (PMPA) envisions an Africa where there is significantly reduced reliance on pharmaceutical imports and reduced proliferation of sub-standard and falsified (SF) medical products on the continent. To contribute to the PMPA agenda, the African Medicines Regulatory Harmonization (AMRH) initiative was established through the African Union Development Agency-NEPAD (AUDA-NEPAD), in 2009 and first launched in the East African Community (EAC) in 2012. Community of West African States (ECOWAS) , the Southern African Development Community (SADC), as well as the Intergovernmental Authority on Development (IGAD) and the Central African Economic and Monetary Community (CEMAC).

The AMRH initiative places emphasis on aligning technical and procedural guidelines for the registration of medicines, diagnostics, devices, vaccines, blood, and blood products. Its scope extends to Good Manufacturing Practice (GMP) inspections, quality management systems, clinical trial oversight, safety monitoring of medical products, and regulatory information management systems. This comprehensive approach operates within a multistakeholder governance framework, fostering critical partnerships with National Medicines Regulatory Authorities (NMRAs), Regional Economic Communities (RECs), and development partners.