EMA medicine monitoring
April 26, 2013
THE European Medicines Agency
has outlined new procedures for
additional post-market monitoring
of certain medications.
An inverted black triangle will
start appearing on the package
leaflet of the affected drugs
from later this year, to “actively
encourage healthcare professionals
and patients to report any
suspected adverse reactions
observed with the medicine”.
Medicines subject to additional
monitoring include those authorised
after 01 Jan 2011 that contain a
new active substance, biological
medicines for which there is
limited post-marketing experience,
medicines with a conditional
approval, and medicines requiring a
post-authorisation safety study.
A medicine can be included on
the list when it is approved for the
first time or at any time during
its lifecycle, and remains under
additional monitoring for five years
or until the EMA decides to remove
it from the list, usually because
studies have further established the
safety profile of the product.
The organisation said the
move was “an important
deliverable of the new European
pharmacovigilance legislation,”
with the holders of marketing
authorisation of medicines on the
list required to update the product
information to include the new
symbol and information by 31 Dec.
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