The Paul-Ehrlich-Institut (PEI) has been involved in the Federal Ministry of Health's (Bundesministerium für Gesundheit, BMG) Global Health Protection Programme (GHPP) since 2016. The three GHPP projects, BloodTrain, VaccRelease, and VaccTrain, have been extended until the end of 2028 and will enter the next project phase in 2026. On this occasion, the Paul-Ehrlich-Institut would like to provide an overview of the partnerships established and milestones achieved thus far, as well as an outlook on specific development goals planned for the three projects.
Since the initiation of the GHPP in 2016, the Paul-Ehrlich-Institut has played an important role in implementing the objectives set in the areas of medicinal product authorisation and medicinal product safety. The Paul-Ehrlich-Institut's three GHPP projects are primarily directed at regulatory authorities in Africa and aim to improve access to safe medicinal products, especially vaccines, as well as blood and blood products. As the next project phase begins, the successful cooperation with international partner institutions will be continued and further developed.
The performance evaluation and official monitoring of in vitro diagnostic medical devices (IVDs) for testing blood makes a decisive contribution to the reliability of the test systems and thus to a safe blood supply. In light of this significance, the BloodTrain project has been working with its African partner countries since 2019 to build up regulatory capacity in the field of IVDs.
Building on several coordinated workshops, the BloodTrain-Next Generation team at the Paul-Ehrlich-Institut, with the active support of other Institute divisions, provided training to twelve regulators from six African medicines authorities at the Paul-Ehrlich-Institut at the end of October 2025. The participants deepened their knowledge about the regulation of IVDs for testing blood in practical training sessions.
This two-week training aimed to bridge the gap between theoretical knowledge and practical application, thus strengthening the skills of the authorities involved in the evaluation and monitoring of IVDs for testing blood. It simultaneously fostered trust and cooperation between the partner institutions involved.
Participants in the IVD training course in the field of blood and employees of the Paul-Ehrlich-Institut.
Source: Paul-Ehrlich-Institut
Under the name BloodTrain Chapter III, the project goal in the upcoming phase is to extend the successful blood regulation support measures provided to the current partner countries, Ghana, Zambia, Zimbabwe, and Tanzania, to now include three additional partners, Namibia, Uganda, and South Africa. There are also plans to use the established expertise of the current partner authorities in joint training courses as a South-South knowledge transfer.
The project will also expand its range of topics to include those in high demand, such as the regulation of plasma-derived medicinal products as well as Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) for blood products.
As vaccine production on the African continent increases, official batch testing plays a central role in ensuring the quality, safety, and efficacy of vaccines. The VaccRelease project therefore specifically supports African partner countries in establishing effective structures for official vaccine batch testing.
As part of the project, four staff members from the Rwanda Food and Drugs Authority (FDA) participated in a seven-week, predominantly laboratory-based training course at the Paul-Ehrlich-Institut between August and November 2025. The aim of the training was to develop technical and regulatory skills in vaccine testing and regulatory batch release procedures.
Participants gained a deeper understanding of the regulatory procedures, documentation, and basic principles of each method, such as testing mRNA vaccines or carrying out a potency test for a combination vaccine against diphtheria, tetanus, and whooping cough and for a vaccine against Haemophilus influenzae type b (Hib).
Training strengthens the ability of the authorities involved to evaluate and release vaccine batches in a well-founded, safe, and independent manner in the future and thus contributes to sustainable quality assurance for the national and regional vaccine supply in Africa.
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The four training participants from Rwanda received training in various laboratory procedures during their time at the Paul-Ehrlich-Institut.
Source: Paul-Ehrlich-Institut
The project will enter into the next project phase under the name VaccRelease 2.0 and will mainly support the partner countries Rwanda and Ghana in the implementation of a robust official batch testing system. The project also contributes to supporting the experienced official control laboratories in South Africa and now also in Egypt in their role as regional regulatory centres of excellence for batch testing and to the training of employees of other control laboratories. In addition, the still young Africa-wide network of official control laboratories (Network of African Reliance Laboratories, NARL) is encouraged to establish additional harmonised regulatory guidelines for batch testing across Africa.
Regulatory documents were developed in cooperation with the partner authorities in the second project phase of VaccTrain 2.0. The documents clarify how adverse reaction reports are processed, evaluated, and communicated and which measures must be taken by authorities to minimise risk.
The Gambian Medicines Control Agency (MCA), funded with the help of the VaccTrain 2.0 project, used these documents as a basis to initiate a nationwide awareness campaign to close communication or knowledge gaps. Agency employees traveled all over the country providing training to groups such as healthcare professionals on various topics, including how side effects are reported within the context of vaccination campaigns, which information is relevant, and how these reports are processed at the agency.
In addition, the Paul-Ehrlich-Institut's VaccTrain 2.0 team was involved in the development of World Health Organization (WHO) guidelines and harmonised assessment tools for reviewing risk management plans (RMPs) and supported the implementation of pilot workshops testing the practical suitability of the tools. These assessment tools help national regulatory authorities to assess new vaccines and medicinal products during the authorisation process and can be adapted to the respective legal requirements of each country.
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Gambian Medicines Agency staff members work with local contacts in various regions during the awareness campaign.
Source: MCA The Gambia
In its third project phase, VaccTrain NEXT aims to further strengthen the scientific and regulatory competencies of the partner authorities in Ghana, Rwanda, and Zimbabwe in clinical trial approval and monitoring procedures. Important stakeholders on the national ethics committees and at research institutes for clinical trials will be explicitly included for the first time.
The project is also active in four new partner countries, Egypt, Botswana, Kenya, and Uganda, reaching a total of seven countries in Africa. On a continental and global level, VaccTrain NEXT continues to support the development of harmonised regulatory standards for the conduct of clinical studies and their implementation in Africa.
Updated: 02.02.2026
