What Paul-Ehrlich-Institut does

Paul-Ehrlich-Institut (PEI) is Germany's federal regulatory institute for vaccines and biomedical medicines, operating as a Bundesinstitut under the Federal Ministry of Health (Bundesministerium f\u00fcr Gesundheit). Founded in 1896 and headquartered in Langen, PEI functions as one of only two national competent authorities in Germany for marketing authorization of human medicinal products\u2014alongside the Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte (BfArM)\u2014with exclusive jurisdiction over vaccines, allergens, antibodies, advanced therapy medicinal products (ATMPs), blood products, tissue preparations, stem cell preparations, and immunological veterinary medicines. The institute serves pharmaceutical and biotech developers, parallel trade companies, allergen product manufacturers, and veterinary immunological product companies operating in or seeking access to the German and EU markets, alongside academic drug developers requiring early scientific advice.

The institute's operational technology comprises regulatory technology infrastructure for vaccine and biomedical medicine evaluation, including pharmacovigilance, haemovigilance, and ATMP vigilance systems; clinical trial management through the EU's CTIS and EudraCT databases; and specialized batch testing laboratory services (the PEI-IVD testing laboratory and the EU Reference Laboratory for In-vitro Diagnostics). PEI houses the ZEPAI (Zentrum f\u00fcr Pandemie-Impfstoffe und -Therapeutika) for pandemic vaccine and therapeutic preparedness, conducts independent quality/efficacy/safety evaluations, performs batch release testing for biological medicines, and provides scientific and procedural advice from discovery through market authorization. It facilitates international collaboration with the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines & Health Care (EDQM), the Heads of Medicines Agencies (HMA), the World Health Organization (WHO), the Global Health Protection Programme (GHPP), and the Global Health Hub Germany (GHH).

As a German federal government institute, PEI is funded through the federal budget and does not operate on a commercial revenue model. Regulatory fee schedules exist for marketing authorization applications, clinical trial approvals, batch testing, and other services, but these are administrative charges rather than market-based pricing. PEI has no private shareholders, venture capital, or independent ownership interests; institutional governance is exercised through its president, Prof. (apl.) Dr. Stefan Vieths, with strategic oversight from the Federal Ministry of Health. Following the October 2024 implementation of the Medizinforschungsgesetz (Medical Research Act), PEI shares a strengthened coordination mandate with BfArM across joint advisory portals, complaint portals, and harmonized application processes via PharmNet.Bund.

Name

Paul-Ehrlich-Institut

Legal name

Paul-Ehrlich-Institut (Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel)

Website

https://pei.de

Company type

Private

Founded year

1896

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Paul-Ehrlich-Institut is Germany's federal regulatory institute for vaccines and biomedical medicines, operating under the Federal Ministry of Health. It evaluates marketing authorizations, clinical trials, batch releases, and pharmacovigilance for vaccines, ATMPs, and related human and veterinary products.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Services

NAICS

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615), Medical Laboratories (621511), Testing Laboratories and Services (541380)

SIC

Biological Products, (No Disgnostic Substances) (2836), Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

Biologics & Vaccine Regulators (HLAJADAB)

akta.pro secondary industries

Vaccine Clinical Development & Regulatory Affairs (HLAIAEAM), Vaccine Quality, Safety & Pharmacovigilance (HLAIAEAL), Vaccine R&D, Clinical/Field Trials & Regulatory Affairs (HLAMAKAM), Veterinary Regulatory Authorities (Licensing, Compliance & Enforcement) (HLAMAJAC)

Keywords

• Vaccine regulation
• Biomedical authorization
• Pharmacovigilance oversight
• Clinical trial approval
• Batch release testing

Headquarters

HQ city

Langen

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Others

Marketing channels7 records

Core offering

Paul-Ehrlich-Institut is Germany's federal regulatory authority for vaccines and biomedical medicines, operating under the Federal Ministry of Health. It evaluates and approves marketing authorizations, clinical trials, and batch release testing for vaccines, allergens, antibodies, ATMPs, blood products, tissue preparations, and immunological veterinary medicines, while providing scientific advice to pharmaceutical developers and conducting post-market pharmacovigilance monitoring.

Product overview

Paul-Ehrlich-Institut (PEI) is Germany\'s federal regulatory agency for vaccines and biomedical medicines, operating under the Federal Ministry of Health. Rather than commercial products, PEI\'s portfolio consists of regulatory substance categories it oversees (vaccines, allergens, antibodies, ATMPs, blood products, tissue preparations, stem cell preparations, and immunological veterinary medicines) alongside regulatory services including scientific advice, clinical trial evaluation, marketing authorization assessment, batch release testing, and pharmacovigilance monitoring. The EMA Allergen Guideline developed under PEI\'s leadership represents a key harmonized framework for allergy diagnostics and therapy across Europe, effective January 2026. PEI collaborates with BfArM through shared portals and coordinated procedures under the Medizinforschungsgesetz (Medical Research Act) to streamline regulatory pathways for pharmaceutical companies and academic drug developers.

Differentiator

Problem solved

Functional benefit

Products and services

• Wissenschaftliche Beratung (Scientific Advice) Early scientific and procedural consultation services supporting drug development from discovery through market authorization, including orientation meetings, scientific advice, pre-submission meetings, and portfolio discussions for pharmaceutical companies developing vaccines and biomedical medicines.
• Klinische Prüfungen (Clinical Trial Evaluation and Approval) Evaluation and approval of clinical trials for vaccines and biomedical medicines in Germany, including GCP compliance and ethics commission coordination, using the EudraCT and CTIS databases.
• Chargenprüfung (Batch Release Testing) State batch release testing for biological medicines including vaccines and immunological products, ensuring quality before market distribution in Germany.
• Zulassung (Marketing Authorization Assessment) Marketing authorization assessment for human and veterinary vaccines, allergens, antibodies, ATMPs, blood products, tissue preparations, stem cell preparations, and immunological veterinary medicines, including parallel import authorization and parallel distribution notification procedures.
• Pharmakovigilanz (Pharmacovigilance Monitoring) Post-market pharmacovigilance monitoring for human vaccines and biomedical medicines, including veterinary pharmacovigilance for immunological veterinary medicinal products (1,852 suspected adverse event reports processed in 2024).
• Haemovigilance, Tissue Vigilance, and ATMP Vigilance Dedicated post-market safety monitoring services for blood products (haemovigilance), tissue preparations (tissue vigilance), and advanced therapy medicinal products (ATMP vigilance).
• EU Reference Laboratory for In-vitro Diagnostics (EURL for IVD) PEI operates the EU Reference Laboratory for In-vitro Diagnostics and the PEI-IVD testing laboratory, providing independent product evaluation and testing services for IVDs across the EU.

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Eight partnerships are on record, tiered minor and core.

• VERAXA Biotech AG (NASDAQ: VRXA)minorOthers · 20 July 2026PEI provided Scientific Advice to VERAXA Biotech on its BiTAC-TCE cancer therapy platform, reviewing the non-clinical development plan and providing regulatory feedback on the dual-targeting, conditionally active therapeutic modality. This reflects PEI's role in providing guidance to biotech companies seeking regulatory approval.
• European Medicines Agency (EMA)coreTechnology or IntegrationPEI collaborates with EMA on European marketing authorization procedures, guideline development (including the new harmonized allergen guideline led by PEI), and regulatory harmonization across EU member states.
• World Health Organization (WHO)coreTechnology or IntegrationPEI serves as a WHO Collaborating Centre and operates WHO-CC annual reporting, contributing to international vaccine and biomedical regulatory standards and pandemic preparedness.
• European Directorate for the Quality of Medicines & Health Care (EDQM)coreTechnology or IntegrationPEI works with EDQM on European quality standards for medicines, certification procedures, and regulatory cooperation for pharmaceutical quality assurance.
• Heads of Medicines Agencies (HMA)coreTechnology or IntegrationPEI participates in the HMA network, coordinating with other European national medicines regulatory authorities on shared regulatory challenges and procedures.
• Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)coreStrategic or Co-development PartnerPEI and BfArM are Germany's two federal superior authorities for medicinal products. They jointly implement the Medizinforschungsgesetz (Medical Research Act), sharing complementary product responsibilities and operating joint advisory portals, complaint portals, and coordinated application processes through PharmNet.Bund.
• Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)coreTechnology or IntegrationPEI works with ZLG's Expert Group 05 'Clinical Trials' which issues votes/opinions on clinical trials conducted in Germany, ensuring harmonized evaluation procedures.
• Global Health Protection Programme (GHPP)coreTechnology or IntegrationPEI participates in the GHPP, contributing to international health protection efforts and pandemic preparedness initiatives.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Regional players

• Therapeutic Goods Administration (TGA): Australia's therapeutic goods regulator, responsible for biologics, vaccines, and blood products. Operates as a national competent authority with a product portfolio similar to PEI's.
• Swissmedic: Swiss national authority for medicinal product authorization and pharmacovigilance. Closely comparable scope and operating model to PEI, though serving a different national market.
• Medicines and Healthcare products Regulatory Agency (MHRA): UK's national regulator, operating independently from the EU post-Brexit. MHRA reviews vaccines and biologics under a national framework comparable in scope to PEI's.
• Pharmaceuticals and Medical Devices Agency (PMDA): Japan's regulator for pharmaceuticals, medical devices, and biologics. Comparable in mandate to PEI, including scientific advice and post-market surveillance for biological products.
• Health Canada — Biologics and Genetic Therapies Directorate: Health Canada's directorate overseeing biologics, vaccines, and genetic therapies. Directly comparable mandate and structure to PEI's vaccine/biologics authority within a national regulatory framework.

Others

• WHO Prequalification Programme: WHO programme assessing vaccines, diagnostics, and medicines for UN procurement. PEI serves as a WHO Collaborating Centre, positioning WHO PQ as a complementary global counterpart to PEI's national work.
• European Directorate for the Quality of Medicines & Health Care (EDQM): Council of Europe body responsible for European Pharmacopoeia standards and CEP certification. PEI partners with EDQM on European quality standards, making EDQM an ecosystem counterpart rather than a direct competitor.

Direct peers

• Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM): Germany's other federal superior authority for human medicinal products. BfArM and PEI jointly implement the Medizinforschungsgesetz and share product responsibilities; directly comparable as a co-equal German national competent authority.

Broad incumbents

• U.S. Food and Drug Administration (FDA): U.S. federal regulator covering biologics, drugs, and devices. Operates the Center for Biologics Evaluation and Research (CBER) with a vaccine/biologics remit directly analogous to PEI's.
• European Medicines Agency (EMA): Pan-EU regulator for human and veterinary medicines. EMA centralizes marketing authorizations across member states, making it the overarching authority PEI contributes to as a national competent authority.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

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Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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