KI coordinates a new EU-funded project in East Africa
Karolinska Institutet and Professor Eleni Aklillu at the Department of Global Public Health leads a new initiative, that aims to enhance the oversight of medicines, medical devices, diagnostics, research ethics, and clinical trials in Tanzania and Rwanda.
Professor Eleni Aklillu at the Department of Global Public Health, Karolinska Institutet, leads a new initiative known as BREEDIME, funded by the European Commission's Global Health EDCTP3 Joint Undertaking.
The project aims to strengthen the regulatory framework and practices related to medicines, medical devices, diagnostics, research ethics, and clinical trials in Tanzania and Rwanda during routine and emergency health situations.
The COVID-19 pandemic highlighted the importance of resilient and efficient regulatory capacities for rapid approval and timely application of health technologies, including diagnostics and medicines.
The challenge of National Medicines Regulatory Authorities and Research Ethics Committees in sub-Saharan Africa to cope with the health emergency during the COVID-19 pandemic prompted the project's initiation.
Karolinska Institutet plays a key role in project coordination, management, training, and capacity-building activities to achieve BREEDIME project objectives. This project can make a significant and lasting impact on healthcare preparedness and regulation in the region.
"Considering the lessons learned from the COVID-19 pandemic, me and my team are committed to contributing to the project's goal to strengthen ethics, regulatory and clinical trial oversight in Tanzania, Zanzibar, and Rwanda. In doing so, we enhance the East African Community's regulatory efficiency to ensure the quality and safety of medicines and vaccines," says Eleni Aklillu.
The BREEDIME Project was officially launched on August 4, 2023, at the Landmark Hotel in Dar Es Salaam, Tanzania, with 42 participants from nine consortium member institutions.
The BREEDIME consortium member institutions lead eight work packages to fortify clinical trial regulatory capacity for therapeutics, vaccines, and diagnostics as well as post-market evaluation in these two East African countries.
- Karolinska Institutet (KI) - Leading "Project Management and Coordination"
- Tanzania Medicines and Devices Authority (TMDA) - Scientific Leader
- National Institute for Medical Research (NIMR) - Leading "Health Research Data Capacity-Building"
- Kilimanjaro Clinical Research Institute (KCRI) - Leading "Communication & Dissemination"
- Muhimbili University of Health and Allied Sciences (MUHAS) - Leading "Training"
- Zanzibar Food and Drug Agency (ZFDA) - Leading "Post Market Surveillance & Appraisal"
- Zanzibar Health Research Institute (ZAHRI) - Leading "Research Ethics Capacity-Building"
- Rwanda Food and Drug Authority (Rwanda FDA) - Leading "Therapeutics & Vaccines"