The Pharmaceutical Manufacturing Plan for Africa (PMPA) led to the establishment of the AMRH Initiative in 2009 to address weak, outdated, and fragmented regulatory systems on the African continent. AMRH, led by the African Union Development Agency-NEPAD (AUDA-NEPAD) was established in collaboration with the National  Regulatory Agencies (NRAs), Regional Economic Communities (RECs), the African Union Commission (AUC), Pan African Parliament (PAP), the World Health Organization (WHO), the Bill and Melinda Gates Foundation (BMGF), the World Bank and other development partners.The AMRH Initiative has so far been implemented in 5 RECs namely, East African Community (EAC), Southern African Development Community (SADC), the Economic Community of West African States (ECOWAS), the Economic Community of Central African States (ECCAS) and, the Intergovernmental Authority for Development (IGAD). In January 2015, the AU Executive Council recognised the AMRH Initiative as the foundation for establishment of the African Medicines Agency (AMA) in advancing the development of the pharmaceutical industry through the
PMPA policy framework. The AMA Treaty was subsequently adopted by the AU Summit in 2019 as a Specialized Agency to improve access to quality, safe and efficacious medical products in Africa. As a result of this global crisis which has had a far more severe impact on the global south1, Africa recognized the urgent need to intensify efforts towards strengthening the capacity of the local manufacturing industry to minimize the impact of medical supply shortages. The work of regulators across the continent has been characterized by high pressure to deliver and ensure access to COVID-19 vaccines and other medical products. Five outcome areas were agreed in 2020 under the AMRH programme to strengthen the continental efforts in the fight against COVID-19. The first outcome was to promote harmonization and reliance across countries, regions, and the continent; while the second focused on country adoption of technical guidelines for regulation of medical products. The third outcome aimed to document and disseminate best practices across RECs and evidence of update of those including development of quarterly newsletters and publication of other information, education, and communication (IEC) materials showcasing AMRH success stories and results. Fourthly, the programme was to communicate the key performance indicators (AMRH KPIs) to all stakeholders at least twice a year. The fifth outcome focused on enhanced performance of AMRH Secretariat in support of the AMRH governance, RECs and partners; while the sixth outcome aimed to ensure that the African Medicines Agency (AMA) is launched by supporting the AMA engagement plan with stakeholders.

Click here to read the full Report