European watchdog to support African drug regulator

The EU medicines regulator, the European Medicines Agency (EMA), has announced plans to support its counterparts in African countries – paving the way for the creation of a single African Medicines Agency (AMA).

The EMA will award a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative which was founded by the African Union Development Agency (AUDA-NEPAD). The move will help to fund 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.

The launch of the African pilot aims 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.

Under the new initiative, 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). This 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 a model for the African regulatory system.