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…