EudraCT

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).

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 an 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

Country Organisation Website
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/
Croatia Agencija za lijekove i medicinske proizvode http://www.almp.hr/
Cyprus Ministry of Health - Pharmaceutical Services http://www.moh.gov.cy/
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/
Finland (N.A.M) http://www.nam.fi/
France Agence Nationale de Sécurité du Médicament (A.N.S.M) http://ansm.sante.fr/
Germany Bundesinstitut für Arzneimittel und Medizinprodukte (B.F.A.R.M) http://www.bfarm.de/
Germany Paul-Ehrlich-Institut (P.E.I) http://www.pei.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/
Iceland Lyfjastofnun (I.M.C.A) http://www.imca.is/
Ireland Irish Medicine Board (I.M.B) http://www.imb.ie/
Italy Agenzia Italiana del Farmaco (A.I.F.A.) 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
Malta Medicines Authority http://medicinesauthority.gov.mt/
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/
Romania Lakemedelsverket http://www.lakemedelsverket.se/
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/
Sweden Lakemedelsverket http://www.lakemedelsverket.se/
UK Medicines and Healthcare products Regulatory Agency (M.H.R.A) http://www.mhra.gov.uk/

Source

See also

External links

This article is issued from Wikipedia - version of the Wednesday, March 23, 2016. The text is available under the Creative Commons Attribution/Share Alike but additional terms may apply for the media files.