Building resilient research ethics, Diagnostics and medicines regulatory capacity during routine and public health emergency periods (BREEDIME)

Framework: Horizon Europe — Global Challenges and European Industrial Competitiveness
Programme: Health
Theme: Public-private partnerships
Destination: Global Health EDCTP3
Action type: Coordination and support actions
Partnership: EDCTP3 (JU-JTI)
Countries involved: Tanzania, United Republic of,United Kingdom,Rwanda,Sweden
Call: Strengthening regulatory capacity for supporting conduct of clinical trials (HORIZON-JU-GH-EDCTP3-2022-01, 2022)
Start date: 2023-06-01
End date: 2026-05-31
Duration (months): 36.0
Total project cost (EUR): 599637.5
EU funding (EUR): 599637.5
Participants: 9
Project status: SIGNED

An effective and strong regulatory system for health technologies is critical, especially during epidemics and pandemic situations. The demand for rapid approval and application of a variety of health technologies including diagnostics and medicines during COVID-19 has reawakened the world to the urgent need to have resilient regulatory capacities that can respond in a timely manner with corresponding efficiency. National Medicines Regulatory Authorities and Research Ethics Committees are duty bound to prepare and be ready to respond in any health emergency. Through EDCTP-2-funded projects namely SMERT, PROFORMA, PAVIA and ASCEND, substantial progress has been made on strengthening some procedures for clinical trial control and pharmacovigilance. These projects have enabled Tanzania to attain WHO Maturity level 3, making it a role model in East Africa. Despite of this, health technologies regulation in Tanzania has struggled to cope with emergencies as witnessed in the COVID-19 pandemics due to limited capacity in the area of Research Ethics, therapeutics, vaccines, medical devices and other health technologies. We now propose BREEDIME to further build our capacity in the context of epidemic and pandemic preparedness. BREEDIME will enable Tanzania to achieve rapid response clinical trial regulatory capacity for therapeutics, vaccines, and diagnostics; capacity for post-market evaluation and appraisal of health technologies; establish research ethics framework for electronic health data and materials storage, access and sharing within and outside the country; and establish a south-south learning centre in clinical trials regulatory and ethical review capacities. These objectives will be achieved through engagement of stakeholders in academia, civil society, public and government to generate evidence to inform new regulatory guidelines. This will strengthen health technologies regulation and will enable rapid access to health care and technology during emergency. Rwanda, which recently established her Food and Drugs Agency will become the first mentee under the BREEDIME south-south networking in ethics and medicines regulatory capacity building. The impact of the outputs of this study will be ensuring safety of pre- and post- registration health technologies in Tanzania and East Africa at large.

Keywords: ethics clinical trials regulatory functions pharmacovigilance diagnostics performance evaluation post market evaluation