Europe's Requirements Stricter

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 placebo.

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.