欧洲公共卫生欧盟参考实验室的建立

Establishment of EU Reference Laboratories forpublic health in Europe 2026 edition 1. Scope and purpose of this document This report describes the legal background and the operational laboratory support context in which theimplementation of the European Reference laboratories (from here on ‘EURLs’) for public health take place. It alsodescribes the ECDC recommended general setup of EURLs and integration into ECDC disease networks as well as A list of all currently designated EURLs, including all consortium members and coordinators, is available on the DGSANTE website [1]. 1.1.Preparation of the document In July 2023, the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) requestedthat ECDC provide it with advice on the establishment of EURLs for public health, in order to support DG SANTE inimplementing responsibilities in this area as set out in Regulations 2022/2370 and 2022/2371 [2,3]. The request asked for advice both on general processes for the implementation of EURLs, as well as a list ofproposed EURLs for communicable diseases. In response, ECDC issued an opinion on the implementation of EURLsfor public health in July 2023, with a revised version issued in April 2024 [4,5]. While these documents were fullyprepared by ECDC, the National Microbiology Focal Points (NMFPs) were consulted on the contents prior to the In June 2025, the opinion was updated as well as split into two documents, since the general process for theimplementation of EURLs for public health is now largely stable: •A technical report on the‘Establishment of EU Reference Laboratories for public health in Europe’. . Thistechnical report contains information on the background and concept of the EURLs for public health as wellas a description of the general EURL implementation process.•Arapid scientific adviceon the designation of future EURLs for public health. This document containsrecommendations on the EURL(s) for public health to be implemented under the next EU4Health Annual This document here is an update of the technical report published in June 2025. This revision of the report reflectsthe situation as of February 2026. It should be noted that ECDC’s work in this area only extends to communicablediseases and other health issues included under ECDC’s mandate. All discussions on EURLs for other areas (e.g. Decisions on which EURL(s) are to be implemented and on general EURL implementation processes are made byDG SANTE. 2. Target audience This report is intended for the following audiences: •DG SANTE, in order to support its decision-making on EURLs for public health; and•Relevant Member State representatives, i.e. National Focal Points and Operational Contact Points nominatedthrough ECDC’s Stakeholder Relationship Management (SRM) system and whose work may be affected by 3. Background 3.1 Legal and technical context 3.1.1 Legislative context ECDC has the mandate to identify, assess, and communicate current and emerging threats to human health fromcommunicable diseases in the EU/EEA. Within this scope, ECDC collects, validates, analyses, and disseminatesroutine surveillance data on notifiable infectious diseases from 30 EU/EEA countries [2,3]. Its mandate also gives In November 2022, two binding legislative acts were published that significantly impacted on ECDC’s mandate andactivities with regards to EU-level laboratory support: •Regulation (EU) 2022/2370 provides an amended mandate for ECDC that strengthens ECDC’s core missionto identify, assess and communicate current and emerging threats to human health from communicablediseases and related special health issues [2]; and 3.1.2 The ECDC disease network model Much of the technical interaction between ECDC and the Member States takes place within the disease networks [6]. Before the creation of ECDC, dedicated surveillance networks (DSNs) in the field of public health were funded bythe European Commission and operated through hubs in different Member States. Under its mandate, ECDC hasbeen given the responsibility for coordinating and operating EU surveillance networks, and most of the DSN To meet these responsibilities, ECDC coordinates a number of EU-wide networks focusing on specificdiseases/health issues. These disease networks include Member State representatives in the form of (at minimum)National Focal Points (NFPs) and Operational Contact Points (OCPs), which are officially nominated by the Member 3.2 Laboratory support through the ECDC disease networks For laboratory aspects, ECDC is mandated to ‘foster the development of sufficient capacity within the Communityfor the diagnosis, detection, identification, and characterisation of infectious agents which may threaten publichealth, by encouraging cooperation between expert and reference laboratories’ [3]. To enhance capabilities andstrengthen laboratory capacities within the disease networks, one or more highly capable network laboratories was collections, supranatio