SEARCH II

The challenge

Effective regulatory systems are essential to protect participants taking part in clinical studies and to safeguard the quality of licensed medical products. The efficiency of such systems is also important to avoid delays in the introduction of new interventions and to ensure that countries are an attractive location for clinical research.

The EDCTP2-funded SEARCH project brought together ministries of health from Botswana, Eswatini, Lesotho, and Mozambique and a European institution to strengthen the capacity of national regulatory authorities and national ethics committees, to promote South–South networking, and to harmonise processes across countries.

The project

In the follow-up SEARCH II project, activities are being extended to new countries, Namibia and Zambia, and an additional European institution has joined the SEARCH consortium.

The aim is to build the capacity of national clinical trial oversight systems, national pharmacovigilance capabilities, and quality assurance processes for licensed products. Existing systems in participating countries will be rigorously assessed and tailored development plans will be put in place for each country. 

Although based on individual countries’ needs, these development plans will include a focus on harmonising, streamlining approaches, and introducing new processes and technologies to improve efficiency. This will make use of the guidance and materials developed by the African Vaccine Regulatory Forum (AVAREF) on harmonisation of regulatory procedures.

An extensive training programme will be organised to build human capacity, including at least 10 short courses. At least five regulatory professionals will have the opportunity to undertake placements within more advanced regulatory systems in Botswana and South Africa.

The project has a strong focus on networking, facilitating the diffusion of expertise, new ideas and technologies through the network. As well as AVAREF, links will be built with the Southern African EDCTP regional Network of Excellence, Trials of Excellence in Southern Africa (TESA), and with the Southern Africa Development Community, both of which have key centres in Botswana. 

Impact

The SEARCH II project will support further strengthening of regulatory systems in countries in Southern and Eastern Africa. It will:

• Promote harmonised approaches across different countries, reducing the administrative burden on sponsors organising multicentre trials.
• Encourage sharing of experience, expertise and tools, helping countries to learn from each other.
• Improve efficiencies and reduce turnaround times for clinical trial applications.
• Lead to improvements in the maturity level of national regulatory authorities.

These impacts will help to protect the safety and interests of research participants during trials, better ensure the safety of medical products, and make the countries more attractive sites in which to carry out clinical research.