EMA launches new EudraCT database

Published: 22-Nov-2013
Regulatory

Version 9 will include summaries of clinical trial results, made available through the EU Clinical Trials Register


The European Medicines Agency (EMA) has launched a new version of the European Clinical Trials Database (EudraCT).

Version 9 will include summaries of clinical trial results, made available through the EU Clinical Trials Register (EU CTR). EudraCT already contains clinical trial information from pharma companies' investigation plans into new paediatric medicines. In a note, EMA encouraged companies 'to register on the EudraCT website to start uploading summary results', which will become public once EMA has launched a new version of the EU CTR, hopefully by the New Year.

European Commission guidance explains what summary content and details that must be posted.

There will be further updates to EudraCT next year, which will, said EMA 'provide improved functionalities for sponsors and EU regulatory authorities'.

It added that EudraCT’s data requirements are already substantially aligned with those of the USA’s ClinicalTrials.gov, with EMA working closely with its operator the USA National Institutes of Health (NIH).

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