October 2023, Cape Town, South Africa

Since January 2023 the twelve “clinical fellows” of the GHPP PharmTrain2 project have been collaboratively working on developing a training manual for clinical assessment of new medicinal products. This manual aims to provide assessors with a standardized and structured approach to training on this multifaceted and complex subject. When completed, this will serve as a sustainable training foundation for the involved national medicine regulatory authorities and their respective regions.

After piloting of the three initial units of the manual within the fellows’ group, trainings were given to a multinational audience at the ZaZiBoNa joint assessment session in Cape Town in October 2023. ZaZiBoNa is the name of the medicines regulation harmonisation initiative of Southern Africa (SADC - Southern African Development Community). Since 2013 assessors have come together to pool resources and pursue a unified approach to reviewing drug applications in the region. The objective of this regulatory collaboration is to expedite the approval processes through work-sharing and harmonisation. This contributes to improving access to safe and effective medications for the population in the SADC region. ZaZiBoNa also serves as a platform for capacity development and information exchange among national medicine regulatory authorities.

This ZaZiBoNa assessment session coincided with the celebration of the initiative’s tenth anniversary. Over time, the number of participating countries has grown from four to the current total of all sixteen SADC countries (Angola, Botswana, Comoros, Democratic Republic of the Congo, Eswatini, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Tanzania, Zambia, and Zimbabwe). Thus, the three trainers, Kulsum Rehemtulla (Tanzania), Hitekani Mabunda (South Africa), and Tobias Siefen (Germany), got the opportunity to train 40 assessors on the topics "The Clinical Contents of the Dossier," "The Study Protocol and Study Report," and "The Clinical Development of Drugs." The audience showed great interest in the training topics and engaged actively in the interactive sessions as well as through posing numerous questions. The concept of the training manual was enthusiastically received by the participants and they look forward to gaining deeper insights into clinical drug evaluation at future events.