The SEARCH (SouthErn Africa Regulatory for Clinical researcH) is an EDCTP-funded project started on 1st January 2021 and lasting 3 years. It is aimed at increasing the regulatory capacities for review of clinical trials in Southern Africa by establishing European-African collaborations that facilitates implementation of efficient processes, harmonized procedures, standardized guidelines and effective training programs in four sub-Saharan countries: Mozambique, Botswana, Lesotho and Eswatini.
The 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 public health research. The overall objectives 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 regulatory stakholders 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 National Regulatory Authorities (NRAs).
Aims and specific objectives
The aim of SEARCH project is to structurally increase the regulatory capacity for clinical trials oversight in Southern African countries, by adopting the specific objectives below listed:
- To develop capacity building for NRAs in clinical trials review, approval and oversight
- To develop and implement a technological platform allowing an enhanced and faster review and approval of the research protocols inside the NRAs, and then to do the same between the other institutions (NECs)
- To create a virtual centralized documentation center for dissemination, communication, and future endeavours on the ethical and regulatory review, approval, oversight and management of clinical trials
- To promote the adoption of AVAREF tools and best practices
- To involve the NEPAD Regional Centres of Regulatory Excellence (RCOREs), as a platform for the development of regulatory training and curricula
- To network with Ethics, Regulatory, and Pharmacovigilance organizations of other African countries and the European Union.
- To develop a stand alone pharmacovigilance policy document and guideline to outline the system for the safety monitoring of adverse events/reactions to all medicines, vaccines, herbal medicines, traditional and alternative remedies.