We performed an analysis comparing the relative speed of regulatory approvals by the FDA and the EMA (European Medicines Agency) for non-insulin–dependent Type 2 diabetes drugs. Our research re-examined a study performed by Downing et al. (NEJM 2012 June 14;366:2284-2293), zeroing in exclusively on new non-insulin–dependent Type 2 diabetes drugs approved between 2005 and 2014. Although Downing et al.’s analysis used the recommendation of the Committee for Medical Products for Human Use (CHMP) as the EMA end point, our analysis uses the European Commission (EC; compiled by the EMA) decision date.
The CHMP date in the original study indicates an initial opinion, but is only an interim end point. The positive EC decision represents the true end of the regulatory process and results in a marketing authorization for the drug. For this reason, we used the EC decision, because it is a truer comparison to FDA approval. Utilizing the same end points allowed us to more effectively compare these two data sets.
Our tightly-focused research reinforced the original study's findings, and the data was quite interesting: 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 nine of the 13 regulatory reviews faster than the EMA. We also noticed that the FDA began its regulatory review at a median time of 103 days sooner than the EMA. In fact, our analysis found that not only do Downing et al.’s findings still hold true, but become even more pronounced when using the more appropriate EMA end point.
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