Eurpoean Medicines Agency Lagging Behind FDA

by Mark S. Senak
EyeOnFDA.com



Last week, a report was issued by the Tufts Center for Drug Development that showed that while the European Medicines Agency (EMEA) - the European Union's FDA equivalent - had met its performance goals, it was nevertheless lagging behind the FDA in approval times.

In terms of review times, the average in the EU was 15.8 months compared to 15.7 months in the US during the period of 2000-2005. According to the report, the agencies approved 71 drugs, but 47 of those were approved more quickly by the FDA than by the EMEA.

That said, if you compare the EMEA to the FDA for the matter of transparency, the FDA also wins hands down. The FDA Web site, for instance, not only lists the meetings of advisory committees, but also posts the transcript of the meeting as well as the slides and supportive materials. The FDA also posts the Warning Letters and has a vast Web site that provides information and therefore, an opportunity for learning. The EMEA provides far fewer such opportunities and the Web site is not exactly consumer-friendly.

One aspect where EMEA is ahead, is that all of the CVs of advisory members are posted on the site, while with FDA, the CVs of most, though not all, committee members are posted by FDA, though often not in a timely manner.


(This article was published by the BioHealth Investor with permission of Mark S. Senak, author of EyeOnFDA.com)


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