EMA & FDA collaborate
December 20, 2013
The European Medicines
Agency (EMA) and Federal
Drug Administration (FDA) have
announced the launch of a generic
medicines application inspections
initiative which enables the two
organisations to share information
on inspections of bioequivalence
studies submitted to them.
The joint initiative also introduces
a mechanism to conduct joint
inspections of facilities where these
studies are conducted.
The EU Member States initially
involved in this initiative are France,
Germany, Italy, the Netherlands
and the United Kingdom.
Additional countries are expected
to join the initiative in the future.
Successful demonstration of
bioequivalence is the basis for the
approval of generic medicines.
Studies submitted in support of
generic medicines applications
must demonstrate scientifically
that the generic medicine is
“bioequivalent”, or performs in
the same manner as the innovator
medicine.
Regulatory authorities inspect
facilities that conduct these studies
to ensure data submitted to the
agencies are of high quality.
The bilateral inspection initiative
includes an 18-month pilot phase,
and builds on the successful 2009
EMA-FDA Good Clinical Practice
(GCP) Initiative, designed to
ensure that clinical trials submitted
in marketing applications for
medicines in the United States and
Europe are conducted ethically and
that the data generated by these
trials are reliable.
For more information CLICK HERE.
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