RegTrain – VaccTrain

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

• Phase I: pilot project

  During this phase, the team established and enhanced ongoing collaborations with key stakeholders in regulatory systems strengthening including the WHO, the African Vaccine Regulatory Forum, and the New Partnership for Africa’s Development – African Medicines Regulatory Harmonization initiative.

  The team collaborated with the WHO in the self-benchmarking of the national regulatory authorities in the Economic Community of West African States in 2017. The goal was to identify strengths and gaps in the national regulatory systems and to define measures to address these gaps (institutional development plan). The self-assessment provided an excellent opportunity for the team to get a deeper understanding of the regulatory needs in the region and potential partner countries.

  To select partner countries for the pilot project, the VaccTrain launched a call for proposals in August 2017. The call was directed at national regulatory authorities seeking to strengthen their capacity in the regulation of clinical trials oversight and willing to work in partnership with other authorities. All the countries from the Economic Community of West African States, Ghana, Liberia, Sierra Leone and The Gambia, requested support for clinical trials oversight and expressed their interest to work with one another. Therefore, they were chosen for the pilot project.

  The VaccTrain team has supported the African Vaccine Regulatory Forum since 2016. The team is particularly lending technical support to the Forum’s clinical trials working group. This working group has developed reviewers’ templates for clinical trial applications and a standardized clinical trial application form. The overarching goal is to introduce standardized templates on the whole continent and thereby further harmonization. The domestication process in the different regional economic communities began in February 2019 with representatives of the Economic Community of West African States, and will continue throughout 2019.

• Phase II: RegTrain - VaccTrain

  As part of the project extension, the VaccTrain team is working together with The Federal Institute for Drugs and Medical Devices (BfArM) to build regulatory capacity in the area of marketing authorizations and pharmacovigilance; thereby increasing the number of regulatory functions addressed by the VaccTrain project from 2017-2019. The geographical scope has been enlarged to include not only the current partner authorities in West Africa, but also the Zimbabwean authority from Southern Africa. This project continues to draw on the experience acquired by the Paul-Erlich-Institut (PEI) and BfArM teams as part of their ongoing support on the continent, and on strategic discussions held with representatives of the WHO, the New Partnership for Africa’s Development, and other international partners. This includes the self-benchmarking assessments in the Economic Community of West African States and the Southern African Development Community, and joint assessments in the East African Community to name a few.

  The project was launched at a meeting in Accra from May 8th to 9th, 2019, with representatives from BfArM, the PEI, ongoing and new partner authorities, and the New Partnership for Africa’s Development.

  As part of this project the teams will work under the byname of “RegTrain.”

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