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RSI in Clinical Trials: EU Authorities set Compliance Date

Further to the publication of new guidance on the RSI in Clinical Trials, the European Authorities have now announced when compliance will be enforced...

As reported to our clients in December 2017, the Heads of Medicines Agencies (HMA) have published a new version of their guidance document entitled “Questions and Answers – Reference Safety Information (RSI)”.

This Q&A document explains what information the RSI should include and how it should be presented. Most importantly, it explains how it should be used in the context of applicable expedited (i.e. SUSAR) and periodic (i.e. DSUR) reporting.

If you have not read our blog post from January 2018 on this topic, you should really take the time and get to know the key messages brought by the new guidance (1).

EU Heads of Agencies set compliance date

The CTFG has now published a Cover Note where it acknowledges that the changes brought by the revised Q&As are significant. Although the document should be considered as applicable from the publication date, the Cover Note refers to a 1-year transition period until National Competent Authorities enforce the new requirements more strictly from 01-Jan-2019.

The MHRA has also updated the guidance on its website accordingly.

Until then, Clinical Trial Applications and/or Substantial Amendment dossiers will not be rejected if the RSI is not completely in line the new Q&As, provided that the IB contains a RSI section that is considered fit for purpose. However the authorities may raise comments on the RSI and the sponsor will be expected to update the IB accordingly at the next routine update.


(1) Safety Observer article – “RSI in Clinical Trials: The EU Guidance explained”, 04-Jan-2018: Link here

(2) Clinical Trial Facilitation Group (CTFG) – CTFG RSI Q&A Cover Note, 08-Mar-2018: Link here

(3) MHRA webpage – Clinical Trial Guidance: Link here

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