Project: Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa

Acronym PROFORMA (Reference Number: CSA2016S-1618)
Duration 01/03/2018 - 28/02/2023
Project Topic Access to medicines in Africa is increasing but inadequate pharmacovigilance regulatory capacity to process new drug registration and monitoring drug safety profiles in indigenous populations remains a challenge. The increasing number of clinical trials and the large-scale mass drug administration and immunizations programs being deployed in Africa underscores the need to strengthen pharmacovigilance system to monitor safety. Lack of skilled manpower to lead and manage the regulatory pharmacovigilance process, and absence of post-marketing surveillance system remains a major gap in Africa. Collaboration between academia, international organizations and national medicine regulatory authorities (NMRAs) are mandatory to produce sustainable regulatory skills and functional national pharmacovigilance system. The PROFORMA consortium constitutes world leading pharmacovigilance experts from WHO collaborating centres in Pharmacovigilance Centre-Lareb, five Medical Universities, four NMRAs (TFDA of Tanzania, PPB of Kenya, FMHACA of Ethiopia, MOH-Rwanda) and two Regional Centre of Regulatory Excellences from East Africa. Our aim is to strengthen the national pharmacovigilance infrastructure and post-marketing surveillance system in Ethiopia, Kenya, Tanzania, and Rwanda. We intend to develop the national pharmacovigilance regulatory training programs by forging partnerships with local academic institutions (training-of-the-trainers for sustainable training programs) and regulatory authorities (practical training to change policy into practice) by using existing structures. Using the WHO Pharmacovigilance Indicators tools, we will first assess the current pharmacovigilance system and practice in Ethiopia, Tanzania, Rwanda and Kenya, to identify the missing pharmacovigilance structural elements systems, strength, deficiencies, and gaps. Based on the identified gaps, comprehensive interventional measures aligned with the local needs and priorities will be introduced in each country. We will map all ongoing pharmacovigilance activities and tools to foster collaborations and to lower duplication. Harmonized pharmacovigilance tools and indicators will be utilized. The main regulatory functions that need capacity building will be identified and prioritized. PROFORMA aims to generate a cohort of pharmacovigilance trained human resources from all stockholders including patients, healthcare providers, regulatory staffs that are engaged in pharmacovigilance data collection, analysis, interpretation and data sharing. Emphasis will be given to implement pharmacovigilance in clinical trials regulation and post-marketing surveillance in public health programmes involving mass drug administration and immunization programmes. A total of 12 postgraduates (4 PhDs + 8 MSc) will be trained to serves as part of the future PV expert regional task force. Our goal is to establish/strengthen sustainable pharmacovigilance system in East Africa that is aligned with the large-scale African medicine regulatory harmonization and WHO’s Pharmacovigilance programme. Project website:
Network EDCTP2
Call Strategic actions supporting health systems/services optimisation research capacities in cooperation with development assistance initiatives

Project partner

Number Name Role Country
1 Karolinska Institutet Coordinator Sweden
2 Addis Ababa University Partner Ethiopia
3 Ethiopian Food, Medicine and Health Care dministration and Control Authority Partner Ethiopia
4 Ministry of Health - Rwanda Partner Rwanda
5 Muhimbili University of Health & Allied Sciences Partner Tanzania
6 Pharmacy and Poisons Board Partner Kenya
8 Stichting Lareb Partner Netherlands
9 Tanzania Food and Drugs Authority Partner Tanzania
10 University of Nairobi Partner Kenya
11 University of Rwanda Partner Rwanda