New project to improve drugs safety in East Africa
In recent years access to drugs and vaccines has been increasing in many African countries, but the systems for monitoring treatment effects and reporting side-effects require further development. Karolinska Institutet will now lead an international collaboration project on pharmacovigilance – drugs safety – in four countries in East Africa.
Those taking part in the project, known as PROFORMA, are researchers from Karolinska Institutet, researchers and experts from universities and regulatory authorities in Ethiopia, Kenya, Tanzania and Rwanda, and some regional and international stakeholders in the field of drugs safety. The total project funding is EUR 6 million, of which the major part is provided by the EU Framework Programme for Research and Innovation-Horizon2020, via the European and Developing Countries Clinical Trials Partnership (EDCTP). Among other significant funding bodies is the Swedish International Development Cooperation Agency (SIDA).
“The main aim of this project is to strengthen the national infrastructures for drugs safety monitoring in our partner countries in Africa. This involves developing regulatory capacity for routine surveillance and reporting, and training of staff working in healthcare and medical services and regulatory authorities,” says Dr Eleni Aklillu, senior researcher at the Department of Laboratory Medicine at Karolinska Institutet and scientific coordinator for the project.
Right now, she is in Ethiopia attending the national kick-off meeting for PROFORMA.
PROFORMA is estimated to last five years. The project also involve training at Master’s and postgraduate level and exchange of knowledge in general between researchers and experts.
“The increasing number of clinical trials and different types of mass drug administration and vaccination programmes in African countries underlines the need to strengthen pharmacovigilance infrastructure. One important tool is to improve collaboration between the Medical Universities and regulatory authorities in the countries concerned, and we’ve already made good progress in this area during the few months we’ve been working on the project,” says Eleni Aklillu.
Facts about PROFORMA
Project title: Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa (PROFORMA)
Project funding: EUR 6 million, to be spread over five years, of which approx EUR 3 million will be funded by Horizon2020/EDCTP. Other funding bodies are SIDA, Karolinska Institutet, the Pharmacy and Poisons Board (Kenya), Muhimbili University of Health and Allied Sciences (Tanzania) and the Tanzania Food and Drugs Authority.
Project period: 1 March 2018 – 28 February 2023 (60 months)
Coordinator: Dr Eleni Aklillu, Associate Professor, Karolinska Institutet.