Project description
Increasing Tanzania’s preparedness for epidemics and pandemics
Authorities and ethics committees must be prepared to respond to pandemics. Funding under the European and Developing Countries Clinical Trials Partnership has assisted Tanzania in improving clinical trial management and drug safety. However, the regulation of health technologies has faced challenges during emergencies such as COVID-19, primarily due to limited capacity. The EU-funded BREEDIME project aims to improve Tanzania’s readiness for epidemics and pandemics. Specifically, it will develop the country’s regulatory capacity for clinical trials related to vaccines, therapeutics and diagnostics, as well as improve its ability to evaluate and assess health technologies once they are in the market. The project will also establish an ethics framework for sharing health data and create a south-south learning centre dedicated to clinical trial regulation.
Objective
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.
Fields of science
- medical and health scienceshealth sciencespublic healthepidemiologypandemics
- medical and health scienceshealth sciencesinfectious diseasesRNA virusescoronaviruses
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines
- social sciencespolitical sciencespolitical policiescivil society
Keywords
Programme(s)
- HORIZON.2.1 - Health Main Programme
Funding Scheme
HORIZON-JU-CSA - HORIZON JU Coordination and Support ActionsCoordinator
17177 Stockholm
Sweden