In contrast to the U.S. Food and Drug Administration (FDA), which is
currently pondering requirements for both acute and long-term efficacy data at
the time a drug-approval application is submitted, the European Agency for the
Evaluation of Medicinal Products (EMEA) began requiring both datasets to be
submitted in late 2002. EMEA oversees drug approvals in the European Union
member countries; however, member countries now retain the right to final
approval to market a drug within their borders. By 2010, drug approvals will
be centralized and regulated by EMEA.
Between 1995 and 2002, EMEA issued a series of guidance documents covering
research and development of psychiatric medications, with each guidance being
specific to a particular disorder. EMEA, at the time of the first submission
of a new drug application for approval, requires submission of data showing
acute efficacy as well as long-term maintenance of response or relapse
prevention. Generally, EMEA requires a trial of at least six months in which
patients who have shown a significant response to the medication under review
are randomly assigned to continue medication or be blindly switched to
The requirements are similar to those that the FDA proposed at the public
hearing of the Psychopharmacologic Drugs Advisory Committee late last month
(see story on page 1).
However, some believe the more stringent European Union requirements have
delayed or prevented approval of medications approved by the FDA using only
acute-treatment data from eight- to 12-week clinical trials.
Detailed information on EMEA requirements are posted at<www.emea.eu.int/>.