The Paul-Ehrlich-Institut (PEI) is committed to the Global Health Protection Programme (GHPP) of the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) through its BloodTrain Chapter III, VaccRelease 2.0, and VaccTrain NEXT projects.
Since the initiation of the GHPP in 2016, the Paul-Ehrlich-Institut has played an important role in the realisation of the objectives in the field of medicinal product authorisation and safety.
The objective of the GHPP is to strengthen health systems at the national, regional, and international levels in order to support our partner countries worldwide, in particular with regard to the prevention and management of outbreaks of disease and the development of resilient health systems. Specialised German scientific institutions operating under the BMG work to reach the GHPP objective by contributing their core competencies internationally for global health protection. In addition to the Paul-Ehrlich-Institut, the BMG has also commissioned the Robert Koch-Institut (RKI), the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), and the Bernhard Nocht Institute for Tropical Medicine (BNITM) with the implementation of the GHPP program.
The Paul-Ehrlich-Institut's three GHPP projects are primarily directed at regulatory authorities in Africa to improve access to safe medicinal products (especially vaccines), blood, and blood products. The focus is on the development of regulatory structures for blood and blood products (BloodTrain Chapter III), the regulation of federal vaccine batch testing (VaccRelease 2.0) and the expansion of regulatory monitoring of clinical trials and medicinal product safety (VaccTrain NEXT).
The Paul-Ehrlich-Institut is closely networked with global partner organisations such as the African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD) and the World Health Organization (WHO). These partners have assumed secretarial functions for the African Medicines Regulatory Harmonization (AMRH) initiative. In the future, AMRH's regulatory activities will be transferred to the African Medicines Agency (AMA). This cooperation across institutions and borders supports the aim of strengthening and harmonising regulatory structures and processes in African countries.
Updated: 02.02.2026
As part of the GHPP programme phase III, the BloodTrain Chapter III follow-up project (running from 2026-2028) is expanding its range of topics to include skill development in the area of blood product and plasma production in Africa and is building on the established partnerships and successes of the first BloodTrain project.
Blood and blood products are important medicinal products. They have been recognised as essential by the WHO. However, blood reserves are not available in sufficient quantity and quality for many countries in Africa. Blood donations and the processing, storing, and testing of donated blood are often inadequately or not at all regulated or monitored. These conditions dramatically increase the risk of transfusion-transmitted diseases, such as HIV or hepatitis viruses.
Source: Paul-Ehrlich-Institut
The GHPP BloodTrain Chapter III team is supporting African partner countries in improving access to safe blood and blood products for patients. A key element in this context is a functioning regulatory structure that guarantees the availability, safety, and quality of blood and blood products. Countries should also be able to respond effectively to crisis situations with sufficient safe blood supplies.
Dr Jens Reinhardt
Deputy Head of the Quality Assessment Coagulation Products and Gene Therapy section
Paul-Ehrlich-Institut
Phone: +49 6103 77 4022
Email: BloodTrain@pei.de
Updated: 02.02.2026
The project enters into the next project phase under the name VaccRelease 2.0 (running from 2026-2028) and will mainly support partner countries in the implementation of a robust official batch testing system.
All these measures serve the overarching goal of improving access to high-quality, safe, and effective vaccines in African countries.
Africa currently produces only one percent of the vaccines it requires. As a result, more and more African governments are calling for the establishment of their own sustainable vaccine industry. This requires a strong regulatory framework, as envisaged in the African Union's 2021 Partnerships for African Vaccine Manufacturing (PAVM) action plan. Such a framework includes the ability to test and release locally manufactured vaccines through an official national control laboratory (NCL).
The VaccRelease 2.0 project works with regulators and laboratory personnel involved in federal testing of vaccine batches. The focus is on the development of expertise and processes for carrying out federal batch testing, in particular on locally produced vaccines. The project also promotes cooperation between national regulatory authorities and national control laboratories in the vaccine-producing countries of Africa as well as with the African Union Development Agency - New Partnership for African Development (AUDA-NEPAD), the African Medicines Quality Forum (AMQF) and other partner organisations.
Dr Heidi Meyer
Head of the Centre for International Cooperation, WHO Unit
Paul-Ehrlich-Institut
Phone +49 6103 77 3106
Email: VaccRel@pei.de
Updated: 02.02.2026
The VaccTrain NEXT follow-up project (running from 2026-2028) builds on the established partnerships and milestones of the VaccTrain project from the previous GHPP funding phases.
Swift access to safe and effective vaccines and medicinal products is crucial for the prevention and control of infectious diseases. During the 2014 Ebola epidemic in West Africa, vaccines and therapeutics were either not available or not available in sufficient quantities to quickly contain the epidemic.
Health systems are often unable to handle such situations. Crucial clinical trials can only be organised with limitations and delays, if at all.
VaccTrain NEXT contributes to building the necessary scientific and regulatory capacities in the area of clinical trials on site in its African partner countries. This involves analysing and evaluating the current situation in the partner countries and identifying weaknesses. VaccTrain NEXT can then create a suitable development program together with the partner authority. The program is then carried out cooperatively. In addition, the project team is committed to the expansion of regional centres of excellence, or RCOREs, in Egypt, Ghana, Kenya, and Zimbabwe. Along with technical and financial support, VaccTrain NEXT provides training to African regulators at the Paul-Ehrlich-Institut, who can then act as instructors and create sustainable regulatory knowledge networks in their home region.
Dr Heidi Meyer
Head of the Centre for International Cooperation, WHO unit
Paul-Ehrlich-Institut
Phone +49 6103 77 3106
Email: VaccTrain@pei.de
Updated: 02.02.2026
