Increasing the regulatory capacities for review of clinical trials in Southern Africa by establishing European-African collaborations that facilitates implementation of efficient processes, harmonised procedures, standardised guidelines and effective training programmes (SEARCH)

Health research is rapidly increasing in quantity and complexity in Africa, and the regulatory landscape in Africa has changed remarkably over the past few years; almost every country in Africa currently having a National Regulatory Agency (NRA). Effective regulatory systems are needed to ensure the quality, safety and efficacy of medical products.

However, it is well recognised that Southern African countries need to have the expertise and capacity to review clinical trial procedures, quality of clinical batches and to monitor trials ongoing in their countries.

The SEARCH (SouthErn Africa Regulatory for Clinical ResearcH) project addresses the identified challenges by aiming at capacity building and focussing on nationally- and regionally- defined research- and regulatory-strengthening initiatives to increase country ownership and commitment to health research.

The overall objective is to focus on establishing harmonised and strong regulatory procedures in the Southern African region and to provide a solid foundation on which a large body of high quality clinical research can be built.

European NRAs will be involved in the SEARCH project as external partners, as they possess efficient, proven and streamlined regulatory procedures, with strong networks, infrastructure and training frameworks.

By providing Standard Operational Procedures (SOPs) and educational materials to participating Southern African NRAs they have the potential to significantly contribute to the strengthening of the regulatory capacity of Southern African NRAs.

This project closely relates to the scope of the EDCTP Regulatory and Ethics capacities call as it will focus on the national regulatory systems and capacities, and more specifically on a structural increase of the capacity of NRAs in Eswatini, Lesotho and Botswana, all naïve countries that have never been involved in such a initiative.

Moreover, this project entails building a sustainable network with partnerships that can support Southern African NRAs (AVAREF, TESA, European NRAs) and implementing efficient SOPs, harmonised guidelines, adequate pharmacovigilance recommendations and training programmes in the Southern African NRAs.

The aimed outcome of the SEARCH project is an increase and strengthening of NRA’s institutional capacities, better qualified personnel and a more efficient, effective and harmonised regulatory pathway for clinical trials evaluation and medicine registration.