BOSTON, MA -- (MARKET WIRE) -- January 16, 2007 -- Review times for new drugs in the European Union
have met mandated performance goals, but many
medicines are available in the United
States prior to the EU, according to a study recently completed by the
Tufts Center for the Study of Drug
Development.
The study found that mean approval times for new products approved in both
the EU and the U.S. during 2000-05 were nearly identical: 15.8 months for
products approved by the European Medicines Agency (EMEA) and 15.7 months
for those approved by the Food and Drug Administration (FDA).
Recently enacted EMEA regulations -- such as conditional marketing
authorization and accelerated assessments, which parallel existing FDA
initiatives -- enabled the agency to meet, or come close to meeting, its
performance timeline goals for all product categories for each approval
stage, the study found.
"While similar development times for new medicines on both continents is
good news for patients, it's especially important for drug developers,
because it enables them to pursue a coordinated global development program
and marketing strategy," said Tufts CSDD Director
Kenneth I Kaitin.
He added, "Looking ahead, we expect that greater collaboration between the
EMEA and FDA will further enhance product development in both regions. It
will also help avoid duplicative testing and provide another way to hold
down development costs."
The study, reported in the January/February Tufts CSDD Impact Report,
released today, also found that:
-- For 71 products receiving both FDA and EMEA approval, the FDA acted
faster than the EMEA in 47 of the cases.
-- While the FDA approved a greater number of products faster than the
EMEA during 2000-05, there was greater variability in FDA approval review
times.
-- Regulatory designation does not appear to have as much impact in the
EMEA as in the U.S., as exceptional circumstance approvals are, on average,
only 1.5 months faster than non-exceptional approvals.
-- Approval times for orphan products in the EU and the U.S. were nearly
identical to those for non-orphan products in the same region.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (
http://csdd.tufts.edu/)
at Tufts University provides strategic information to help drug developers,
regulators, and policy makers improve the quality and efficiency of
pharmaceutical development, review, and
utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth
analyses on pharmaceutical issues and hosts symposia, workshops, and public
forums on related topics, and publishes the
Tufts CSDD
Impact Report, a bi-monthly newsletter providing analysis and insight
into critical drug development issues.
Contact Information: Contacts:
Tufts Center for the Study of Drug Development
Peg Hewitt
617-636-2185
Email Contact
Business Communication Strategies
Peter Lowy
781-326-9980
Email Contact