On 23 April 2025, experts from the Paul-Ehrlich-Institut exchanged views with representatives of the German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie e.V., BPI) and the pharmaceutical manufacturers and developers organised within the BPI. The Paul-Ehrlich-Institut has held annual meetings with the BPI and other associations since 2010. Regular and open dialogue is important in regards to the common goals of providing safe and effective medicines and driving innovation. In addition to an update on the Paul-Ehrlich-Institut's regulatory activities, the topics of this year's meeting included the implementation of the EU Directive for substances of human origin (SoHO), clinical research, animal testing replacement methods, digitalisation, and the Medical Research Act.
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Participants in this year's dialogue between the Paul-Ehrlich-Institut and the German Pharmaceutical Industry Association.
Source: Paul-Ehrlich-Institut
Biomedicines and vaccines with a marketing authorisation in the European Economic Area (EEA) are generally authorised by the European Commission for all Member States under centralised authorisation procedures. The European Medicines Agency (EMA) coordinates these procedures, during which experts from the national medicines authorities carry out the benefit-risk assessment. Professor Stefan Vieths, President of the Paul-Ehrlich-Institut, reported on the Institute's current contributions to EMA authorisation procedures and clinical trial approvals at the BPI meeting. He reported that 809 applications for clinical trials were submitted in Germany in 2024 (previous year: 805 applications). A total of 351 of the submissions were applications for clinical trials of vaccines and biomedicines. The participants also discussed their experiences with the use of the Clinical Trials Information System (CTIS) in connection with the Clinical Trials Regulation (CTR).
Another topic discussed at the meeting was the Medical Research Act (Medizinforschungsgesetz, MFG). The implementation of the MFG involves the close cooperation of the two higher federal authorities: the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). Their efforts include making regulatory procedures more efficient through harmonisation and facilitating pharmaceutical companies' access to such procedures. The MFG, which has been in force since 30 October 2024, aims to increase Germany's attractiveness as a location for the development of innovative medicines and medical research.
Other dialogue topics were the implementation of the new EU Directive for substances of human origin (SoHO), replacement methods for animal testing, scientific advice, and digitalisation. The Paul-Ehrlich-Institut also provided information on the status of the KIMERBA project. The KIMERBA project is a research project funded by the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) and led by the Paul-Ehrlich-Institut to investigate the applicability of artificial intelligence (AI) in regulatory processes.
The regular meetings with the BPI promote practical exchanges on the diverse regulatory and scientific issues that occur along the entire development cycle of vaccines and biomedicines.
Updated: 23.04.2025
