The Paul-Ehrlich-Institut participates in international committees to ensure the quality, safety and efficacy of vaccines and biomedicines worldwide.
The Paul-Ehrlich-Institut actively supports the World Health Organization (WHO) through its two WHO Collaborating Centres: "Quality Assurance of Blood Products and in vitro Diagnostic Devices" and "Standardization and Evaluation of Vaccines". Both were redesignated in 2021 for an additional 4 years. Experts from the Paul-Ehrlich-Institut are also involved in actions such as the preparation of globally valid regulatory guidelines for vaccines and the establishment of international reference material (WHO International Standards [ISS], reference panels, reference preparations). These guidelines and standards are regularly presented, discussed, and adopted by the WHO Expert Committee on Biological Standardization (ECBS). Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut, chaired the biannual ECBS meetings as Chair/Co-Chair.
The rapid development of global guidelines for regulatory evaluations of mRNA-based vaccines was particularly noteworthy. By October 2021 it had already been adopted by the ECBS.
Prof Dr Klaus Cichutek (President of the Paul-Ehrlich-Institut)
October 2021 also saw the establishment of a new WHO Advisory Group on Blood Regulation, Availability and Safety (AG-BRAS), chaired by Dr Anneliese Hilger. The newly founded working group advises the WHO on regulation and technical aspects of blood and blood product supply at all levels.
The medicines authorities exchange information at the European level in various working groups of the HMA (Heads of Medicines Agencies; group of heads of medicines authorities of the EU/EEA Member States). At the international level, experts exchange views in the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA discussions included topics such as current approaches to COVID-19 vaccine regulation and COVID-19 vaccine safety. The Paul-Ehrlich-Institut also contributed its expertise to ICMRA workshops.
The HMA works closely with the European Medicines Agency (EMA), because national medicines authorities experts from the EU/EEA Member States (National Competent Authorities; NCAs) carry out assessments in the EMA committees and subsequently issue opinions. The EMA was entrusted by the European Commission with the development of the Clinical Trials Information System (CTIS). CTIS use has been mandatory for the application for approval of clinical trials in the EU since January 2023. Together with the European Commission and the EMA, the HMA launched the ACT EU (Accelerating Clinical Trials) initiative in January 2022 to make clinical trials in the EU more attractive to drug developers along with the new legal measures. The HMA was also preparing for the revision of the EU pharmaceutical legislation. NCA experts, including those from the Paul-Ehrlich-Institut, contributed to 13 concept papers for the European Commission.