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PROFORMA project is funded by European Union’s Framework Programme for Research and Innovation Horizon 2020 via the European and Developing Countries Clinical Trials Partnership Association (EDCTP2).

Access to medicines in Africa is increasing but inadequate pharmacovigilance regulatory capacity to process new drug registration and monitoring drug safety profiles locally remains a challenge. The increasing number of clinical trials and the large-scale mass drug administration and immunizations programs being deployed through public health programmes in sub Sharan Africa underscores the urgent need to develop/strengthen the pharmacovigilance system for patient safety.

Lack of skilled manpower to lead and manage the regulatory pharmacovigilance process, and the absence of effective post-marketing surveillance system remains a major gap in Africa. PROFORMA strives to fill this gap by forging partnerships between local academic institutions (training-of-the-trainers for sustainability) and national medicine regulatory authorities (practical training to change policy into practice) by using existing structures in Ethiopia, Kenya, Tanzania, and Rwanda.

The PROFORMA consortium is a joint venture between academia, regulatory authorities, Reginal and Global pharmacovigilance stakeholders from

  • Five Medical Universities:
    • Karolinska Institutet, Sweden (Associate Professor Eleni Aklillu, co-ordinator)
    • Collage of Health sciences, Addis Ababa University, Ethiopia
    • School of Pharmacy, University of Nairobi, Kenya
    • School of Pharmacy- Muhimbili University of Health and Allied Sciences (SoP-MUHAS), Tanzania
    • University of Rwanda, Rwanda
  • Four National medicine regulatory authorities:
    • Ethiopian Food, Medicine and Health Care Administration and Authority (EFMHACA),
    • Pharmacy and Poisons Board (PPB), Kenya
    • Tanzania Food & Drugs Authority (TFDA), Tanzania
    • Ministry of Health, Rwanda,
    • Two Regional Centre of Regulatory Excellences (RCOREs) in Africa
      • PPB: RCORE in Pharmacovigilance.
      • TFDA and SoP-MUHAS: RCORE in medicine evaluation and registration
    • WHO collaborating centres in Pharmacovigilance Centre-Lareb
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Supported by EU
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Short facts

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

Acronym: PROFORMA

Collaborative Project: Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

Grant agreement: CSA2016S-1618

Project Coordinator: Associate Professor Eleni Aklillu, PhD – Karolinska Institutet, Sweden

Project start date: March 1, 2018

Duration:  5 years (60 months)

Total project value: EUR 6,000,000

EDCTP grant amount: EUR 3,000,000

Co-funding from: Pharmacy and Poisons Board (Kenya), Karolinska Institutet (Sweden), Swedish International Development Cooperation Agency (Sweden), Muhimbili University of Health & Allied Sciences (Tanzania), Tanzania Food and Drugs Authority (Tanzania).

Funding Organization: EDCTP

  • European and Developing Countries Clinical Trials Partnership-2: the EDCTP2 programme is supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.
  • Sida, Swedish International Development Cooperation Agency.