EMA launches new structure
September 17, 2013
The European Medicines Agency
overnight released details of its
new organisational structure,
with the changes “fundamentally
reorganising the Agency’s
operations to support better its
public and animal health mission”.
The new structure sees the EMA
having four new core divisions, with
responsibilities right through the
lifecycle of medicines for human
use, from development to use in
patients.
The four human medicine
divisions are: Human Medicines
Research and Development
Support; Human Medicines
Evaluation; Procedure Management
and Business Support; and
Inspections and Human Medicines
Pharmacovigilance.
The reorganisation separates
the scientific and procedure
management functions of the EMA.
“With the increasing number
and complexity of applications
being handled by the Agency’s
committees, this is intended to
reinforce the robustness and
quality of the Agency’ output and
allow development of greater
specialities able to respond
and support the work of the
committees,” the EMA said.
Veterinary medicines are also
managed through a single Division
that has been refocused to deal
solely with animal health, while
a new Division for Stakeholders
and Communication has also
been created to provide improved
coordination of the Agency’s
relations with stakeholders.
New advisory roles have been
created including Chief Policy
Adviser and Head of Programme
Design Board, adding to the existing
functions of Senior Medical Officer,
International Affairs, Audit and the
Legal department.
“The changes announced today
will reshape the EMA so that it is
ready to handle future challenges
and seize opportunities,” said EMA
executive director Guido Rasi.
“My aim is to give our scientific
committees the best possible
support...to help them keep
delivering high-quality, consistent
opinions,” he added.
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