As reported in the December 2017 issue of Safety Observer, the Heads of
Medicines Agencies (HMA) have published a new version of their guidance
document entitled “Questions and Answers – Reference Safety Information (RSI)”.
The new Q&As 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: link here
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.
Thierry Hamard (LinkedIn Profile) is a Pharmacist with more than 15 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.
Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.
