Regulatory review of novel therapeutics--comparison of three regulatory agencies.

ABSTRACT:

Background

The upcoming reauthorization of the Prescription Drug User Fee Act focuses on improving the review process for new drug applications at the Food and Drug Administration (FDA).

Methods

Using publicly available information from the FDA, the European Medicines Agency (EMA), and Health Canada, we compared the time for completion of the first review and the total review time for all applications involving novel therapeutic agents approved by the three regulatory agencies from 2001 through 2010 and determined the geographic area in which each novel therapeutic agent was first approved for use.

Results

There were 510 applications for novel therapeutic agents approved from 2001 through 2010--225 by the FDA, 186 by the EMA, and 99 by Health Canada; among the applica

SUBMITTER: Downing NS 

PROVIDER: S-EPMC3504361 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature