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with the aim of having user acceptance testing in October 2015 and these new functionalities available
by December 2015.
12.3.3. Periodic Safety Update Single Assessment (PSUSA)
PRAC assessment report publication
The topic was deferred to a later PRAC meeting.
12.3.4. Union Reference Date List
Consultation on the draft list, version March 2015
Feedback from the Granularity and Periodicity Advisory Group (GPAG)
The PRAC was updated on the activities of the GPAG, composed of PRAC delegates and EMA staff
members, focussing on harmonising and streamlining the EURD list and welcomed the progress being
made.
The PRAC endorsed the draft revised EURD list version March 2015 reflecting the PRAC comments
impacting on the DLP and PSUR submission frequencies of the substances/combinations. The PRAC
endorsed the newly allocated Rapporteurs for upcoming PSUSAs in accordance with the principles
previously endorsed by the PRAC (see PRAC Minutes April 2013).
Post-meeting note: following the PRAC meeting in March 2015, the updated EURD list was adopted by
the CHMP and CMDh at their March 2015 meeting and published on the EMA website on 01/04/2015,
see:
Home> Human Regulatory>Pharmacovigilance>Periodic safety update reports>EURD list> List of
Union reference dates and frequency of submission of periodic safety update reports (PSURs)
12.4. Signal Management
12.4.1. Signal Management
Feedback from Signal Management Review Technical (SMART) Working Group
At the organisational matters teleconference held on 26 March 2015, the PRAC was updated on the
outcome of the March 2015 SMART Working Group meeting, where the results of the EudraVigilance
analysis on interstitial lung disease (ILD) were discussed. This topic will be further discussed in future
SMART Working Group meetings. A review and a proposal for an update to designated medical events
were presented and will be further discussed at the next SMART Working Group meeting. Finally, the
publication of PRAC recommendations on signals for updates to the product information in all EU
languages which started for the January 2015 relevant signals, was further discussed in particular the
timing of implementation of labelling changes. The standard for MAHs to submit a variation is 60-days
from publication of the English text. It was discussed whether the 60-days should count from the
publication of the translations and publish them earlier i.e. at the same time as English text.
Post-meeting note: following consultation of the Coordination Group for Mutual Recognition and
Decentralised Procedures – Human (CMDh) it was agreed to publish the English text and the
translations at the same time.
Statistical guideline update
At the organisational matters teleconference held on 26 March 2015, the EMA secretariat presented a
proposal to review the current guideline on the use of statistical signal detection methods in the
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 56/89