EudraCT

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EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. The EudraCT database has been established in accordance with Directive 2001/20/EC. The EudraCT Number is unique and is needed on other documents relating to the trials (e.g. SUSAR reports). No new EudraCT numbers are issued since February 2023. They have been replaced by EU CT numbers.

Contents

Public Side

The public side of EudraCT is for organisations to register any of their clinical trials as defined by Directive 2001/20/EC. The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial. The public side of EudraCT does not save any of the trial detail entered by the user, and instead provides a saved data file in the form of an XML which the user must store on their own local hard drive.

Applying for an EudraCT Number

Application for a EudraCT number is made via the EudraCT website. To generate the EudraCT number some basic information about the requestor's organisation and the trial is required:

Once the requestor submits the form, the EudraCT Number will be assigned and an e-mail called "EudraCT Receipt" sent. The EudraCT number has the format YYYY-NNNNNN-CC, where:

The Clinical Trial Application (CTA) form is also created via the EudraCT system.

Version details

The EudraCT database is currently on Version 9.

Current Versions

Version 9 of EudraCT was released in November 2013.

New features for Version 9 include:

Protocol-related information

Sponsors can:

PIP addressees can:

Result-related information

Results users can:

Member States

CountryOrganisationWebsite
AustriaBundesamt für Sicherheit im Gesundheitswesen (BASG) http://www.basg.at/
BelgiumFederaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (AFMPS) http://www.fagg-afmps.be/
BulgariaBulgarian Drug Agency (BDA) http://www.bda.bg/
CroatiaAgencija za lijekove i medicinske proizvode http://www.almp.hr/
CyprusMinistry of Health - Pharmaceutical Services http://www.moh.gov.cy/
Czech RepublicStátní ústav pro kontrolu léčiv (SÚKL) http://www.sukl.cz/
DenmarkDanish Medicines Agency (DKMA) http://laegemiddelstyrelsen.dk/
EstoniaState Agency of Medicines (SAM) http://www.ravimiamet.ee/
Finland Fimea http://www.fimea.fi/
FranceAgence Nationale de Sécurité du Médicament (ANSM) http://ansm.sante.fr/
GermanyBundesinstitut für Arzneimittel und Medizinprodukte (BfArM) http://www.bfarm.de/
GermanyPaul-Ehrlich-Institut (PEI) http://www.pei.de/
GreeceNational Organisation for Medicines (EOF) http://www.eof.gr/
HungaryNational Institute of Pharmacy and Nutrition (OGYÉI) https://www.ogyei.gov.hu/
IcelandLyfjastofnun (IMCA) https://web.archive.org/web/20111003224256/http://www.imca.is/
IrelandHealth Products Regulatory Authority (HPRA) http://www.hpra.ie/
ItalyAgenzia Italiana del Farmaco (AIFA) http://www.agenziafarmaco.gov.it/
LatviaZalu Valsts Agentura (ZVA) http://www.zva.gov.lv/
LiechtensteinAmt für Gesundheit (AG) https://web.archive.org/web/20111024152641/http://www.ag.llv.li/
LithuaniaValstybine Vaistu Kontroles Tarnyba (VVKT) http://www.vvkt.lt/
LuxembourgDivision de la Pharmacie et des Medicaments http://www.etat.lu/MS
MaltaMedicines Authority http://medicinesauthority.gov.mt/
NetherlandsCentrale Commissie Mensgebonden Onderzoek (CCMO) http://www.ccmo.nl/
NorwayStatens Legemiddelverk (NOMA) http://www.noma.no/
PolandUrząd Rejestracji Produktów Leczniczych (URPL) http://www.urpl.gov.pl/
PortugalAutoridade National do Medicamento e Produtos de Saude I.P. (Infarmed) http://www.infarmed.pt/
RomaniaAgentia Nationala a Medicamentului si Dispozitivelor Medicale (ANMDM) https://www.anm.ro/
SlovakiaSlovakia Medicines Agency http://www.sukl.sk/
SloveniaJavna Agencija Republike Slovenije za Zdravila in Medicinske Prioimocke (JAZMP) http://www.jazmp.si/
Spain Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es/
SwedenLakemedelsverket http://www.lakemedelsverket.se/
UKMedicines and Healthcare Products Regulatory Agency (MHRA) http://www.mhra.gov.uk/

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