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).
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 a 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 organization and the trial is required:
- Requestor's organisation name, town/city and country
- Sponsor's protocol code number
- Requestor name
- E-mail to which the EudraCT number will be sent
- Security code
- Whether the clinical trial is contained in a Paediatric Investigation Plan (PIP)
- Whether the clinical trial will be conducted in a third country (outside of the EU/EEA)
- The Member States where it is anticipated that the trial will be run
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:
- YYYY is the year in which the number is issued.
- NNNNNN is a six digit sequential number.
- CC is a check digit.
The Clinical Trial Application (CTA) form is also created via the EudraCT system.
The EudraCT database is currently on Version 9.
Version 8 was released in March 2011 and involved a major change to the EudraCT system, and how the data is stored. These changes were made in preparation for the launch of the Clinical Trials Register which is a public database that displays information from within EudraCT.
New features in version 8 are:
- Utility to convert EudraCT V7 XMLs to V8 XMLs
- EudraCT updated to include trial Pediatric information
- EU Clinical Trials Register 
Version 9 of EudraCT was scheduled for release in 2012 but appears to have been delayed, and there is currently no news on a potential launch date for this update.
New features planned for Version 9 include:
- Publishing of Summary Reports to the database for all Trials
- Summary Reports being made available to view on the Clinical Trials Register
- Phase I studies viewable on Clinical Trials Register
|Austria||Bundesamt für Sicherheit im Gesundheitswesen (B.A.S.G)||http://www.basg.at/|
|Belgium||Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (A.F.M.P.S)||http://www.fagg-afmps.be/|
|Bulgaria||Bulgarian Drug Agency (B.D.A)||http://www.bda.bg/|
|Cyprus||Ministry of Health - Pharmaceutical Services|
|Czech Republic||Státní ústav pro kontrolu léčiv (S.U.K.L)||http://www.sukl.cz/|
|Denmark||Danish Medicines Agency (D.K.M.A)||http://laegemiddelstyrelsen.dk/|
|Estonia||State Agency of Medicines (S.A.M)||http://www.ravimiamet.ee/|
|France||Agence Française de Sécurité Sanitaire des Produits de Santé (A.F.S.S.A.P.S)||http://www.afssaps.fr/|
|Germany||Bundesinstitut für Arzneimittel und Medizinprodukte (B.F.A.R.M)||http://www.bfarm.de/|
|Greece||National Organisation for Medicines (E.O.F)||http:// www.eof.gr|
|Hungary||National Institute of Pharmacy (O.G.Y.I)||http://www.ogyi.hu/|
|Ireland||Irish Medicine Board (I.M.B)||http://www.imb.ie/|
|Italy||Agenzia Italiana del Framaco (A.I.F)||http://www.agenziafarmaco.gov.it/|
|Latvia||Zalu Valsts Agentura (Z.V.A)||http://www.zva.gov.lv/|
|Liechtenstein||Amt für Gesundheit (A.G)||http://www.ag.llv.li/|
|Lithuania||Valstybine Vaistu Kontroles Tarnyba (V.V.K.T)||http://www.vvkt.lt/|
|Luxembourg||Division de la Pharmacie et des Medicaments||http;//www.etat.lu/MS|
|Netherlands||Centrale Commissie Mensgebonden Onderzoek (C.C.M.O)||http://www.ccmo.nl/|
|Norway||Statens Legemiddelverk (N.O.M.A)||http://www.noma.no/|
|Poland||Urzad Rejestracji Produktow Leczniczych (U.R.P.L)||http://www.urpl.gov.pl/|
|Portugal||Autoridade National do Medicamento e Produtos de Saude I.P.||http://www.infarmed.pt/|
|Slovakia||Slovakia Medicines Agency||http://www.sukl.sk/|
|Slovenia||Javna Agencija Republike Slovenije za Zdravila in Medicinske Prioimocke (J.A.Z.M.P)||http://www.jazmp.si/|
|Spain||Agencia Espanola de Medicamentos y Productos Sanitarios (A.E.M.P.S)||http://www.aemps.gob.es/|
|UK||Medicines and Healthcare products Regulatory Agency (M.H.R.A)||http://www.mhra.gov.uk/|