EMA’s better public health
February 7, 2012
THE European Medicines agency
is currently preparing for
fundamental changes to
pharmaceutical legislation due to
come into effect this year, aimed at
improving public health protection
across the 27 EU Member States.
The new pharmacovigilance
legislation will come into effect in
July this year and will include the
formation of the new
Pharmacovigilance Risk
Assessment Committee, as well as
a revision of the mandate of the
existing Coordination Group for
Mutual Recognition and
Decentralised Procedures –
Human, to strengthen its role in
pharmacovigilance.
As part of the shake-up the
Agency will increase its
transparency by publishing the
agendas, recommendations,
opinions and minutes from its
scientific committees, and will also
organise public hearings allowing
the public to engage with the
Agency on safety issues.
In addition any patient in
European Member States will be
able to report suspected adverse
drug reactions to his or her
national medicines authority,
whilst the Agency will also begin to
operate a new urgent Union
procedure for safety issues
concerning nationally and centrally
authorised medicines.
The Agency will also this year
implement the procedure for
protocol approval of postmarketing
safety studies and results
management initially only for
centrally authorised drugs, and will
develop a revised process for the
coordination of pharmacovigilance
inspections during the year.
The revised process for signal
detection for centrally authorised
medicines will start as of July 2012,
with additional data support being
provided to the European Member
States for nationally authorised
products.
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