EMEA Submissions
The European Agency for the Evaluation of Medicinal
Products became operational on Jan. 1st 1995. The
agency is responsible for running the centralised
procedure and supporting all work performed by the
Committee for Proprietary Medicinal Products, the
CHMP. Besides the centralised procedure, the CHMP's
working parties are concentrated under the roof of
the EMEA, like the Pharmacovigilance Working Party
or the Biotech Working Party. The role of the Working
Parties can be described as the policy and guidance
developing bodies with additional tasks like searching
for pharmacovigilance issues in a certain class of
drugs or in a particular drug. A further significant
task performed by the CHMP is the scientific advice
procedure.
The EMEA is also home of the COMP, the
Committee for Orphan Medicinal Products.
Due to our involvement in more than 30 centralised,
more than 50 decentralised, and more than 25 global
submissions we are able to offer a wealth of experience
in dealing with the EMEA and its bodies. We provide
input into and/or organise:
