Paul-Ehrlich-Institut

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EMRN

European Medicines Regulatory Network

The European Medicines Regulatory Network (EMRN) is a joint, decentralised platform composed of the national competent authorities (NCA) of the Member States of the European Economic Area (EEA), the European Medicines Agency (EMA), and the European Commission. The aim of the network is close cooperation and division of labour in all matters relating to medicinal product authorisation and monitoring within Europe.

The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) represent Germany as national competent authorities in the EMRN and are actively involved in European regulation.

The EMRN has been recognised as a single-entity (SE) regulatory framework by the World Health Organization (WHO) and designated as a "WHO-Listed Authority" (WLA). WLAs meet all relevant indicators and requirements defined by WHO for the recognition of regulatory competence pursuant to a defined benchmarking and performance evaluation process.

In its role as a WLA, the EMRN embraces and actively supports cooperation with regulatory authorities in third countries. This collaboration aims to strengthen global regulatory systems, promote mutual reliance, and enhance public health worldwide.

For direct contact with other National Competent Authorities within the EMRN, please refer to the NCA contact list on the Heads of Medicines Agencies (HMA) website.

Updated: 22.12.2025