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Reference Safety Information – update from the Clinical Trials Facilition Group

03 October 2013

The Clinical Trial Facilitation Group (CTFG) has drawn up a document on Reference Safety Information (RSI). It describes the requirements for the RSI when submitting an application for a new trial, but also what to do in ongoing trials.

The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements.

Reference Safety Information (RSI) for a Clinical Trial