Global Health Protection Programme (GHPP)
Global Health Protection Programme (GHPP)
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 Next Generation, VaccRelease, and VaccTrain 2.0 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 Next Generation), the regulation of federal vaccine batch testing (VaccRelease) and the expansion of regulatory monitoring of clinical trials and medicinal product safety (VaccTrain 2.0).
Cooperation with African Partner Organisations
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 initiative of African Medicines Regulatory Harmonization (AMRH) and the African Vaccines Regulatory Forum (AVAREF). This cooperation across institutions and borders supports the aim of strengthening and harmonising regulatory structures and processes in African countries.
GHPP Project BloodTrain Next Generation
GHPP Project BloodTrain Next Generation
As part of the GHPP programme phase II, the BloodTrain Next Generation follow-up project (runs from 2023-2025) is building on the established partnerships and successes of the first BloodTrain project.
Objectives
- Improving the availability, safety, and quality of blood and blood products
- Supporting the establishment of a regulatory structure and its adaptation to crisis situations in partner countries
- Supporting the establishment of regulation of in vitro diagnostic medical devices for safe and reliable blood testing
Project Description
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.
The GHPP BloodTrain Next Generation 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.
Project Lead
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
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GHPP Project VaccRelease
GHPP Project VaccRelease
Objectives
- Development of regulatory capacities and competencies for federal batch testing in African vaccine-producing countries
- Supporting national regulatory authorities and official control laboratories in drawing up an institutional development plan for vaccine batch release
- Supporting official control laboratories in the development of policies, processes, and procedures for conducting federal batch testing
- Training in vaccine-specific experimental tests
- upporting the establishment of an Africa-wide network (system of reliance) for batch testing and the mutual recognition of batch testing
All these measures serve the overarching goal of improving access to high-quality, safe, and effective vaccines in African countries.
Project Description
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 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.
Project Lead
Dr Heidi Meyer
Head of the Centre for International Cooperation, WHO Unit
Paul-Ehrlich-Institut
Phone +49 6103 77 3106
Email: VaccRel@pei.de
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GHPP Project VaccTrain 2.0
GHPP Project VaccTrain 2.0
The VaccTrain 2.0 follow-up project (runs from 2023-2025) builds on the established partnerships and milestones of the RegTrain-VaccTrain project from the first GHPP funding phase.
Objectives
- Supporting the development of scientific and regulatory capacities for the approval and monitoring of clinical trials
- Supporting the development of sustainable structures to monitor the safety of medicinal products, and of vaccines in particular (pharmacovigilance)
- Contributing to permanently improving universal access to safe and effective medicinal products, in particular vaccines
- Promoting Africa-wide harmonisation of regulatory processes
Project Description
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 2.0 contributes to building the necessary scientific and regulatory capacities in the areas of clinical trials and medicinal product safety on site in its African partner countries. This involves analysing and evaluating the current situation in the partner countries and identifying weaknesses. VaccTrain 2.0 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 Ghana and Zimbabwe. Along with technical and financial support, VaccTrain 2.0 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.
Project Head
Dr Heidi Meyer
Head of the Centre for International Cooperation, WHO unit
Paul-Ehrlich-Institut
Phone +49 6103 77 3106
Email: VaccTrain@pei.de
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