RegTrain – VaccTrain

Regulatory Training and Advice in the Field of Vaccines and Biomedical Therapeutics

Short Description

The Ebola epidemic in West Africa has shown that vaccines and therapeutics are not readily available to control an epidemic quickly. In many cases, health systems are overwhelmed under those conditions. Essential clinical trials can only take place with restrictions and delays, if at all.

The RegTrain-VaccTrain project aims to support the development of the scientific and regulatory capacity necessary to address these challenges in African partner countries. The purpose is to establish a harmonized regulatory framework on the continent and to encourage cooperation between different African national regulatory authorities. These activities are conducted in close collaboration with the World Health Organization (WHO) and various African and international organizations.

An important element in this project is the assessment and analysis of the current regulatory system in partner countries, especially for marketing authorizations, pharmacovigilance, and clinical trials. These results are then used to create a development program together with the selected countries.

Objectives of the Project

  • to strengthen national regulatory authorities
  • to promote universal access to medicines, especially vaccines, to improve global health standards permanently
  • to contribute to the achievement of the WHO Millennium Goals, especially to reduce maternal and infant mortality



01.01.2016 - 31.12.2022


ca. 538,000 EUR

Partner Countries

  • The Gambia
  • Ghana
  • Liberia
  • Sierra Leone
  • Zimbabwe

Implementing Institution


Project phases

In Cooperation with

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

Publications and Presentations

Last update: December 2022