Descrizione del progetto
Aumentare la preparazione della Tanzania alle epidemie e alle pandemie
Le autorità e i comitati etici devono essere preparati a rispondere alle pandemie. Il finanziamento nell’ambito del Partenariato Europa-paesi in via di sviluppo per gli studi clinici ha aiutato la Tanzania a migliorare la gestione degli studi clinici e la sicurezza dei farmaci. Tuttavia, la regolamentazione delle tecnologie sanitarie ha dovuto affrontare sfide durante le emergenze come quella da COVID-19, principalmente a causa della capacità limitata. Il progetto BREEDIME, finanziato dall’UE, mira a migliorare la preparazione della Tanzania ad affrontare epidemie e pandemie. In particolare, svilupperà la capacità normativa del paese per le sperimentazioni cliniche relative a vaccini, terapie e diagnostica, oltre a migliorare la capacità di valutare le tecnologie sanitarie una volta immesse sul mercato. Il progetto stabilirà anche un quadro etico per la condivisione dei dati sanitari e creerà un centro di apprendimento sud-sud dedicato alla regolamentazione degli studi clinici.
Obiettivo
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.
Campo scientifico
- 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
Parole chiave
Programma(i)
- HORIZON.2.1 - Health Main Programme
Argomento(i)
Meccanismo di finanziamento
HORIZON-JU-CSA - HORIZON JU Coordination and Support ActionsCoordinatore
17177 Stockholm
Svezia