The EudraCT PUBLIC applications for creating the Clinical Trial Application Form (Annex 1 pdf and xml) have been upgraded to v10.5.0.0. The upgraded version should allow a more user friendly completion of the form.

For clinical trials in which there is no sponsor or representative of the sponsor who is domiciled in a Member State of the EU or in the EEA at the time when a so-called hard Brexit becomes effective, revocation or suspension of the con-duct of the trial is mandatory by law. Such clinical trials may then not be continued.

Should there be no specific agreements regarding medicinal products between the European Union (EU) and the United Kingdom (UK), the following issues concerning clinical trials with medicinal products must be observed after
the United Kingdom has withdrawn from the EU on 29 March 2019 (Brexit)

EudraCT has made multimedia tutorials for clinical trial results available on its website.

Section 3a of the Ordinance on the Prescription of Medicinal Products ("Arzneimittelverschrei­bungsverordnung", AMVV) of 21 December 2005 (BGBl. I p. 3632) as last amended by Article 1 of the Ordinance of 19 February 2013 (BGBl. I p. 312) applies to the use of medicinal products containing thalidomide, lenalidomide or pomalidomide, in clinical trials.

BfArM provides information on GLP requirements of non-clinical studies in clincal trials .

A new Template issued by the European Commission for the qualified person’s declaration on GMP compliance

Answers to frequently asked questions regarding the new form of annual safety report, the DSUR, have been harmonised on the European level by the Clinical Trial Facilitation Group (CTFG).