Building Regulatory Capacities and Infrastructure: Marketing Authorisation of Medicinal Products

Fellows für klinisches Assessment treffen das PharmTrain team, WHO Experten und Mitarbeitende im Bundesinstitut für Arzneimittel und Medizinprodukte (Quelle: BfArM)
Fellows for Clinical Assessment meet the PharmTrain team, WHO experts, and staff at BfArM in Germany (source: BfArM)


Global health crises are on the rise, especially those caused by infectious disease outbreaks, and pose a serious threat to health and well-being. WHO estimates that up to 10 million lives could be saved every year if access to safe and effective medicines and vaccines were improved. As a World Health Assembly resolution on this subject highlights, stable, well-functioning health care systems are urgently needed to ensure timely access to quality medical products, which will help countries prevent and respond effectively to health crises. Despite considerable advances in recent years, the capacity to improve access to essential medical products through regulation is still limited in many regions, including sub-Saharan Africa. The project therefore aims to strengthen regulatory infrastructure and the capacity of partnering authorities to evaluate the pharmaceutical quality, efficacy and safety of medicinal products (“regulatory infrastructure”). This will improve the quality, consistency and efficiency of regulatory decision-making. PharmTrain2 also strongly promotes medicines regulation harmonisation in Africa. The activities build on the achievements of the RegTrain-PharmTrain project and involve working with staff from the medicines regulatory authorities in the seven partner countries and supporting AUDA-NEPAD in operationalising the African Medicines Agency (AMA).


Strengthening the institutional development of selected African medicines regulatory authorities in the field of marketing authorisation of medicinal products.

In Cooperation with

  • African Union Development Agency, New Partnership for Africa’s Development (AUDA-NEPAD)
  • Food and Drugs Authority (FDA), Ghana
  • Liberia Medicines and Health Products Regulatory Authority (LMHRA), Liberia
  • Medicines Control Agency (MCA), The Gambia
  • Medicines Control Authority of Zimbabwe (MCAZ), Zimbabwe
  • Pharmacy Board of Sierra Leone (PBSL), Sierra Leone
  • South African Health Products Regulatory Authority (SAHPRA), South Africa
  • Tanzania Medicines and Medical Devices Authority (TMDA), Tanzania
  • World Health Organization (WHO), Switzerland

Thematic priorities

  • Marketing authorisation and safety of medicinal products
  • Resolutions and international agreements
  • Strengthening of public health systems



01.01.2023 - 31.12.2025


ca. 1,800,000 Euro

Partner Countries

  • The Gambia
  • Ghana
  • Liberia
  • Sierra Leone
  • South Africa
  • Tanzania
  • Zimbabwe


Dr. Regine Lehnert
Federal Institute for Drugs and Medical Devices (BfArM)
Kurt-Georg-Kiesinger Allee 3,
53175 Bonn, Germany


  • Staff deployment and exchange

    Training staff from national medicines regulatory authorities to become trainers in drug evaluation for marketing authorization and related procedures, with a focus on biosimilars and the clinical assessment of pharmaceuticals.

  • Networking and cooperation

    Fostering harmonisation initiatives and the scale-up of guidelines from the regional to the continental level; for example, supporting the Technical Committees on Evaluation of Medical Products and Regulatory Capacity Building of the African Union Development Agency, the New Partnership for Africa’s Development (AUDA-NEPAD), and thereby contributing to the operationalisation of AMA.

  • Capacity development

    Strengthening regulatory frameworks by developing structural documents (e.g. guidelines and standard operating procedures); supporting regulatory authorities in developing harmonised regulatory guidelines and procedures.