Description du projet
Renforcer la préparation de la Tanzanie aux épidémies et aux pandémies
Les autorités et les comités d’éthique doivent être prêts à réagir aux pandémies. Le financement accordé dans le cadre du partenariat des pays européens et en développement sur les essais cliniques a aidé la Tanzanie à améliorer la gestion de ses essais cliniques et la sécurité de ses médicaments. Toutefois, la réglementation des technologies de la santé s’est heurtée à des difficultés dans le contexte de situations d’urgence telles que la COVID-19, principalement en raison de capacités limitées. Le projet BREEDIME, financé par l’UE, entend améliorer la préparation de la Tanzanie aux épidémies et aux pandémies. Plus précisément, il développera la capacité réglementaire du pays dans le cadre des essais cliniques liés aux vaccins, aux thérapies et aux diagnostics, et améliorera sa capacité à évaluer les technologies de la santé une fois sur le marché. Le projet établira également un cadre éthique pour le partage des données de santé et créera un centre d’apprentissage Sud-Sud dédié à la réglementation des essais cliniques.
Objectif
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.
Champ scientifique
- 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
Mots‑clés
Programme(s)
- HORIZON.2.1 - Health Main Programme
Régime de financement
HORIZON-JU-CSA - HORIZON JU Coordination and Support ActionsCoordinateur
17177 Stockholm
Suède