June 2023, Bonn, Germany

Ten assessors from the national medicines regulatory authorities (NMRAs) of Ghana FDA, Zimbabwe MCAZ, South African SAHPRA, and Tanzania TMDA recently concluded their participation in workshop as part of the Clinical Fellowship at the BfArM. The clinical fellowship’s main purpose is to enhance regulatory expertise and foster collaboration among African NMRAs. The ongoing fellowship of the GHPP PharmTrain2 project has demonstrated its value as a platform for the fellows to develop expertise in regulatory topics with a strong focus on the clinical assessment of marketing authorisation applications.

The two-week workshop, hosted by the BfArM, was dedicated to the practical assessment of dossiers in the field of infectious diseases with the assistance of long-standing BfArM professionals. The fellows gained valuable insights into the European concepts of work-sharing and reliance, including the unique opportunity to observe the multinational discussions at meetings of the European Medicines Agency (EMA), such as the Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). Beyond, the fellowship offered a visit to a clinical research organisation and lively discussions with WHO experts on substandard and falsified medicines. A two-day expert seminar in didactics and communication refreshed the fellows’ training skills.

Through the intensive collaboration and exchange while at the BfArM, the fellows deepened their professional and personal relationships. As evidenced by their great enthusiasm for the annual on-site workshop, the fellows are committed to the continuous development of their skills and expertise. This solidifies their roles as potential future leading experts for the African Medicines Agency (AMA) in clinical assessment. Moreover, by becoming expert trainers, the assessors will play a vital role in strengthening regulatory capacity and ensuring a safer and more efficient regulatory process for medicinal products on the African continent.