Building and Enhancing Regulatory Capacity in Africa (BERC - Africa)

In response to the need to increase access to health technologies and bolster innovation, the New Partnership for African Development (NEPAD) agency launched efforts to designate Regional Centres of Regulatory Excellence (RCOREs) in Africa. RCOREs aim to improve the safety and quality of health technologies by strengthening regulatory capacity in African Union member states providing academic and technical training in regulatory science applicable to different regulatory functions and managerial aspects. The Food and Drugs Authority (FDA), Ghana, as a RCORE, in collaboration with the School of Public Health, University of Ghana, developed a training manual for use by NEPAD designated RCOREs to deliver training programmes in clinical trials to regulatory personnel across National Medicines Regulatory Agencies (NMRAs) in Africa. The four week fellowship course covers three major areas: Clinical Trial Authorisation, Clinical Trial Monitoring and Regulatory Attachment. Piloting of the manual's use began in 2017 and has continued till 2019 with a total of 34 regulators from 10 African countries trained so far. Due to rapid geographic spread of infectious diseases of public health concern, such as Lassa fever, Ebola, Marburg haemorrhagic fever, Dengue fever and Nipah virus, etc., clinical trials related to these diseases are gradually increasing. Hence, there is the need for improved and expanded regulatory systems to address such issues. This can be achieved through identifying relevant capacity building training for regulators in the sub-region, such as the RCORE Fellowship Training in Clinical Trials and specific training in areas related to clinical trials. An upscale of the already existing RCORE Fellowship training programme and other capacity building activities for African regulators in the area of clinical trials will help to address this need. The aim is to: Train regulators from National Medicines Regulatory Agencies (NMRAs) under the RCORE Fellowship Training, including those from Francophone countries Training and mobility actions for African regulators, including trainers of RCORE trainees (short term training courses) Coordination and support actions to enhance regulatory activities, including industrial attachments. At the end of the 36 month period, a full comprehensive report will be submitted to EDCTP and any results/data from the training shall be published on FDA’s website as well as in its DrugLens newsletter. Presentations will also be made at forums relevant to clinical trials, such as the EDCTP Forum.