FDA quicker on approval trigger than EU: study
Consultancy ContextMatters, in a research blog post, took hold of a study from The New England Journal of Medicine that found that the FDA “provided more rapid reviews of applications involving novel therapeutics” than its European and Canadian counterparts.
ContextMatters researchers cited what the group perceived as a flaw in the study's methodology. NEJM assumed an FDA approval was akin to approval by the EU's CHMP (Committee for Medicinal Products for Human Use) regulatory body. CHMP's nod, however, is not the equivalent of an FDA approval—drugs must still receive final approval from the European Commission before they can be marketed throughout the EU. The implication, not surprisingly, is that the difference in approval time would be even more pronounced when comparing apples to apples.
"We found that the FDA was consistently first and faster than its European counterpart to approve the 13 new treatments, with the FDA approving 11 ahead of the EMA, and completing 9 of the 13 regulatory reviews faster than the EMA," the group wrote. "We also noted that the FDA began its regulatory review before the EMA at a median time of 103 days sooner."