Paul-Ehrlich-Institut is committed to the global health protection – exchange with international foundation
From 30 July to 7 August 2018, Dr. David Mukanga of the Bill & Melinda Gates Foundation (BMGF) visited the Paul-Ehrlich-Institut (PEI) to inform himself on the institute’s commitment and expertise in the field of marketing authorizations of medicines. Both players are committed to strengthen national health systems in Africa and to push through the implementation of international health regulations. The PEI has been involved in the Global Health Protection Programme (GHPP) of the German Federal Ministry of Health ever since 2017.
During his visit, Mr Mukanga took the opportunity to gain direct insights in the work of the experts at PEI. The Gates Foundation is familiar with the medical infrastructures on the African continent and is an important partner to PEI in establishing health systems in Africa.
PEI supports this partnership with two important subjects: expertise in vaccines and biomedical products and experience in its role as a leading medicines authority in Europe.
"I have gotten a much better understanding of how PEI operates and offers its expertise with the EMA network. The co-operation between regulatory authorities in Europe is an important model for further developments in Africa," as Mr Mukanga summarized.
The PEI had already hosted a workshop for experts from 17 African countries and NEPAD ("New Partnership for Africa´s Development"), the World Health Organization (WHO), the US medicines authority FDA and other experts from Europe and Canada in December 2017.
A discussion took place at the workshop at PEI, which was financially supported by the Federal Ministry of Health, the "Center for Biologics Evaluation and Research" (CBER), the US FDA, and the WHO, concerning joint strategies for harmonizing regulatory structures and standards. The aim was to find ways and means of strengthening existing health systems and promoting their co-operation within Africa, thus contributing in a sustained manner to the health care of the population even in crisis situations.
NEPAD, the New Partnership for Africa´s Development is an economic development program of the African Union and an important partner in the GHPP. In the project "African Medicines Regulatory Harmonization" (AMRH), NEPAD pursues the goal of setting standards in the context of the regulation and improvement of access to safe and high-quality medicines for the population in Africa.
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The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.
Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.
The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organisation, European Medicines Agency, European Commission, Council of Europe etc.).