BREEDIME

The challenge

Multiple countries in sub-Saharan Africa have made significant upgrades to their regulatory systems over the past two decades. However, the capabilities of regulatory systems vary markedly between countries, and remain underdeveloped in many. This is a significant barrier to hosting additional clinical studies.

Multiple EDCTP2-funded projects, including ASCEND, PAVIA, PROFORMA, and SMERT, have helped build regulatory, pharmacovigilance, and research ethics capacity in Tanzania. These projects have made an important contribution to the progression of the Tanzanian national regulatory authority to the WHO maturity level 3. It is also recognised as a Regional Centre of Regulatory Excellence (RCORE). 

However, the COVID-19 pandemic revealed significant capacity gaps, particularly in the approval and oversight of clinical research during health emergencies. In addition, medical interventions are becoming increasingly complex, specialist knowledge is needed to assess in vitro diagnostics, and clinical trial design is constantly evolving. Such developments present new challenges to those involved in oversight of clinical research.

The challenge

The BREEDIME project focuses on regulatory capacity development in key areas of clinical research in Tanzania and on leveraging these efforts to strengthen regulatory systems in Rwanda, which only established a national medicines regulatory authority in 2018.

Training courses are being organised on key aspects of clinical research during health emergencies. The project will also focus on building national expertise in areas such as post-market evaluation, enabling regulatory staff to conduct product information reviews and ensure that manufacturers’ descriptions of medical products are accurate. 

The project will also develop an ethics framework for the sharing of materials and health data during health emergencies, drawing on established European standards. 

This additional expertise in Tanzania will provide a basis for stronger South–South capacity building, with Tanzania providing support to Rwanda’s newly established national regulatory authority.

Impact

The BREEDIME project will further enhance regulatory capacity in Tanzania. It will:

• Help to close key gaps in expertise, particularly relating to regulatory oversight of clinical research during health emergencies. 
• Enable Tanzania to support regulatory capacity development in neighbouring countries, particularly Rwanda.
• Create new partnerships to support ongoing sharing of expertise and experience.

These project activities will further consolidate Tanzania's status as a favoured site for clinical research in sub-Saharan Africa and enable it to better fulfil its role as a regional centre of regulatory excellence.