From Wikipedia,
the free encyclopedia
The European Medicines
Agency (EMEA) is a
European agency for the
evaluation of
medicinal products. Until
2004, the European Medicines
Agency was known as The
European Agency for the Evaluation
of Medicine.
Roughly parallel to the
U.S.
Food and Drug Administration
(FDA), but without FDA-style
centralization, the EMEA was
set up in
1995 with funding from the
European Union and the
pharmaceutical industry, as well
as indirect subsidy from member
states, in an attempt to harmonize
(but not replace) the work of
existing national
medicine regulatory bodies.
The hope is that this plan will
not only reduce the $350 million
annual cost drug companies incur
by having to win separate
approvals from each member state
but also that it will eliminate
the
protectionist tendencies of
states unwilling to approve
new drugs that might compete with
those already produced by domestic
drug companies. The EU is
currently the source of about
one-third of the new drugs brought
onto the world market each year.
Based in
London, the EMEA was born
after more than seven years of
negotiations among EU governments
and replaced the Committee for
Proprietary Medicinal Products set
up in
1977 and the Committee for
Veterinary Medicinal Products,
though both of these were reborn
as the core scientific advisory
committees.
Set up by EC Regulation No.
2309/93 as the European Agency for
the Evaluation of Medicinal
Products, and renamed by EC
Regulation No. 726/2004 as the
European Medicines Agency, it has
retained the acronym EMEA
througout.
A pharmaceutical company
submits an application for a
marketing authorisation to the
EMEA. A single evaluation is
carried out through the Committee
for Medicinal Products for Human
Use (CHMP) or Committee for
Medicinal Products for Veterinary
Use (CVMP). If the relevant
Committee concludes that quality,
safety and efficacy of the
medicinal product is sufficiently
proven, it adopts a positive
opinion. This is sent to the
European Commission to be
transformed into a marketing
authorisation valid for the whole
of the European Union. The EMEA's
Committee on Orphan Medicinal
Products (COMP) administers the
granting of
orphan drug status.
The majority of existing
medicines throughout the European
Union's member states remain
authorised nationally, but the
majority of genuinely novel
medicines are authorised through
the EMEA.
The Agency has a staff of about
360, and
decentralizes its scientific
assessment of medicines by working
through a computer-linked network
of about 3500 experts throughout
the EU. The CHMP and CVMP are
obliged by the Regulation to reach
decisions within 210 days, though
the clock is stopped if it is
necessary to ask the applicant for
clarification or further
supporting data. This compares
well with the average of 500 days
taken by the U.S.
FDA.
