Exelixis Inc (EXEL)

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PICTURE CAPTION (pg 15) On average the EMA takes around six months more than the FDA to approve a new drug or new indication for a drug. This is mainly due to time lost to clock stop and the delay between getting a positive CHMP opinion and approval from the European Commission. Furthermore, in the US almost all cancer drugs are approved under priority review, whereas accelerated assessment is rarely used by the EMA Source: CDER 21st Century Review Process (www.fda.gov); User Guide for Micro, Small and Medium-sized Enterprises (www.ema.europa.eu) *Day 150 for accelerated assessment; Rap – Rapporteur TABLE CAPTION (pg 17) Numbers indicate time to final approval from the European Commission, with time to positive opinion from EMA’s Committee for Medicinal Products for Human Use given in parentheses; b under review at time of publication; c Priority review procedure used Source: Adapted from RR Shah, SA Roberts and DR Shah. (2013) Br J Clin Pharmacol 76:369–411 Time to approval (days) for tkis in the EU and US
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http://www.cancerworld.org/Articles/Issues/58/January-February-2014/Cutting-Edge/637/Approval-rating-how-do-the-EMA-and-FDA-compare.html

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