Strengthening Regulatory Capacities for Clinical Trials Oversight in Southern Africa: South-South and South-North Collaboration Initiative for Regulatory Bodies.

The Southern Africa Regulatory for Clinical Research (SEARCH) is a consortium established in 2020 under the second program of the EDCTP, designed to develop and promote a framework for collaboration, harmonization process and support regulatory capacity and develop technical expertise in Southern African countries to support the conduct of clinical trials (CT).

It is composed of four institutions from Southern Africa and one European.

In this proposal, SEARCH II, eight institutions come together to strengthen and increase the capacities for the clinical trials review process in Southern Africa built from the SEARCH I project, including the issuance of relevant permits, CT oversight and clinical research pharmacovigilance and post-trial market authorisation by NRAs.

However, insufficient access to quality, safe, efficacious and affordable medical products in Southern Africa has imposed significant challenges on public health for decades.

This, in part, is attributed to weakness or absence of technical expertise, lack of policies, guidelines and regulatory systems, a lack of competent regulatory professionals in the National Medicines Regulatory Authority (NMRAs) and ineffective regional collaborations among the NRAs and NECs.

In response to these regulatory challenges, the SEARCH I project initiated a process of regional harmonisation efforts and conducted SWOT analysis among the southern African members, and developed a comprehensive common plan for continuous improvement and overcoming gaps at the beneficiary country level and effective harmonization of regulatory and ethical review processes.

The SEARCH II project aims to support the national regulatory capacity system, develop technical expertise and continue promoting the South-South and North-South collaboration built from the SEARCH I project, while also enhancing and advocating the establishment and structuring of NRAs and NECs in Botswana, Eswatini, Lesotho, Mozambique, Namibia and Zambia.