The Paul-Ehrlich-Institut (PEI) is Germany’s federal authority for vaccines and biomedicines, responsible for regulating defined classes of human and veterinary biological medicinal products and conducting associated scientific research. It is a higher federal authority within the remit of the [Federal Ministry of Health (Germany)], with its headquarters in Langen, Hesse. According to Germany’s foundational law establishing the institute (BASIG) and the institute’s own overview, PEI’s remit spans marketing authorisation, clinical trial oversight, official batch testing, and medicines safety for products in its scope. Gesetze-im-Internet (BASIG); Paul-Ehrlich-Institut – Official Duties; BMG – PEI profile.

Legal status and mandate

PEI’s legal foundation is the Gesetz über das Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel (BASIG) of 7 July 1972, which establishes the institute as an independent federal authority; subsequent amendments (including 2009) updated the name to its current form. Gesetze-im-Internet (BASIG). Under §77 of Germany’s Medicinal Products Act (Arzneimittelgesetz, AMG), PEI—not BfArM—is the competent higher federal authority for sera, vaccines, blood preparations, tissues and tissue preparations, allergens, advanced therapy medicinal products (ATMPs), xenogeneic medicinal products, and genetically engineered blood components. §77 AMG; Paul-Ehrlich-Institut – Official Duties. For vaccines, sera, and allergens placed on the German market, §32 AMG requires official batch testing and release by the competent authority; PEI performs this function nationally and as an Official Medicines Control Laboratory (OMCL) within the EU OCABR system. PEI – FAQ: Batch Testing; EDQM – Questions and answers on OCABR.

Responsibilities and activities

PEI evaluates applications for marketing authorisations for products in its remit via national, mutual-recognition, decentralised, or (where applicable) EMA-coordinated procedures; for human use, it handles defined biological classes under national and EU law. PEI – Authorisations (human); Paul-Ehrlich-Institut – Official Duties; BMG – PEI profile. For immunological veterinary medicinal products, monoclonal antibodies for immunotherapy in animals, veterinary novel-therapy immunologicals, and animal allergens, PEI is the German competent authority under Regulation (EU) 2019/6 and national veterinary legislation. PEI – Marketing Authorisation (Veterinary). PEI authorises clinical trials in Germany for vaccines and biomedicines in its remit, taking ethics committee opinions into account; procedure and legal basis are outlined in its clinical trials guidance. PEI – Clinical Trials; PEI – FAQ Clinical Trials. Pharmacovigilance is a core PEI duty; suspected adverse reactions for vaccines and relevant biomedicines can be reported via the federal portal, and data feed into EudraVigilance at the EU level. PEI – Pharmacovigilance (human); nebenwirkungen.bund.de; PEI – Data on Adverse Drug Reactions; BfArM blog on reporting. As an OMCL, PEI conducts experimental batch testing and grants batch release for defined biologicals, with EU-wide mutual recognition via OCABR certificates; PEI describes timelines and scope for mRNA vaccines and other products. PEI – FAQ: Batch Testing; PEI – Certificates (human); PEI – Experimental Batch Testing; EDQM – Questions and answers on OCABR. ATMPs are principally subject to central EU authorisation via the European Medicines Agency, though national approvals exist under narrow conditions; PEI provides public guidance warning against commercial offers of unauthorized ATMPs. PEI – News on unauthorised ATMPs (31 Mar 2025).

International roles and reference functions

PEI hosts two World Health Organization Collaborating Centres: one for the standardization and evaluation of vaccines and another for quality assurance of blood products and in vitro diagnostics; the latter was redesignated for 2025–2029. PEI – WHO Collaborating Centres overview; PEI – WHO CC redesignation news (2025). The institute is also a designated EU Reference Laboratory (EURL) for in vitro diagnostic medical devices (class D) in the categories “hepatitis and retroviruses” and “highly pathogenic respiratory viruses,” with operations beginning 1 October 2024. European Commission – EURL designation news (6 Dec 2023); PEI – Press release on EURL designation; PEI – EURL for IVDs page. PEI’s public vaccine-safety information is part of WHO’s Vaccine Safety Net, reflecting internationally vetted standards for vaccine-safety communication. WHO – Vaccine Safety Net (PEI member page).

History

The institute began in 1896 when Paul Ehrlich became director of the newly created Institute for Serum Research and Serum Testing in Steglitz near Berlin; in 1899 it relocated to Frankfurt/Main as the Royal Institute for Experimental Therapy. PEI – History (Chronology); Britannica – Paul Ehrlich. It was renamed Paul-Ehrlich-Institut in 1947 and, by the 1972 federal act, became an independent higher federal authority. PEI – History (Chronology); Gesetze-im-Internet (BASIG). A partial move to Langen (Hesse) occurred in 1987, with inauguration of the Langen site in 1990, consolidating the headquarters south of Frankfurt am Main. PEI – History (Chronology).

Organisation and leadership

PEI reports to the Federal Ministry of Health and operates as a higher federal authority with regulatory, scientific, and reference-laboratory functions. BMG – PEI profile. Professor Stefan Vieths, a long‑standing PEI vice president and acting head in 2024, was appointed president effective 1 January 2025. PEI – Press release: Stefan Vieths appointed president.

Pandemic preparedness and ZEPAI

In 2021, the Federal Ministry of Health established the Zentrum für Pandemie‑Impfstoffe und ‑Therapeutika (ZEPAI) at PEI to ensure preparedness for rapid procurement, production capacity, logistics, and distribution of pandemic vaccines and therapeutics in Germany; the centre coordinates supply chains and distribution with digital monitoring. PEI – ZEPAI (German); PEI – ZEPAI fields of action; PEI – Press release launching ZEPAI (2021).

Facilities and location

The institute’s headquarters address is Paul‑Ehrlich‑Straße 51–59, 63225 Langen, Hesse, Germany, accessible from Frankfurt Airport and regional rail. PEI – Getting to PEI. PEI collaborates extensively with national partners, including the Robert Koch Institute, and European bodies such as the European Medicines Agency and the EDQM OMCL network. RKI – Associated institutions: PEI; EDQM – Questions and answers on OCABR; BMG – PEI profile.