Validating processes is an important step towards establishment of African Medicines Agency, EMA has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of the African Union Development Agency (AUDA-NEPAD) to support a pilot to test procedures for the joint continental evaluation of medicines in Africa.
AUDA-NEPAD has been working on harmonisation activities for a decade, paving the way for the creation of the African Medicines Agency (AMA). The launch of the continental pilot is one of these activities that aim to validate procedures and processes ahead of the establishment of the AMA. The pilot, which is co-funded with the Bill & Melinda Gates Foundation, will run for a year.
During the pilot, the AMRH Evaluation of Medicinal Products Technical Committee (EMP-TC) will evaluate the quality, safety and efficacy of priority medicinal products with the support of the continental Good Manufacturing Practices Technical Committee (GMP-TC). The learnings from the evaluations will help to develop continental processes and procedures, facilitate national authorisations of recommended medicines and strengthen information sharing and reliance. The two AMRH technical committees visited EMA in June 2024 to share knowledge and get insights into EMA’s regulatory procedures and processes, which could serve as possible model for the African continental regulatory system.
EMA and the European medicines regulatory network (EMRN) will continue making available their unique experience and expertise in continental medicines regulation to support the establishment of the AMA by providing technical expertise and training both online and in person. EMA’s involvement in the AMA project officially started in December 2023 when the Agency received a contribution from the European Commission to support the setting up of the AMA. The project forms part of the European Union (EU) Global Gateway strategy and Team Europe Initiative on Manufacturing and Access to Vaccines, Medicines and Health Technologies (‘MAV+’).
