Where do you want to launch first?


In a recent article published by RAPS (2015), identified that in 2104 Japan was the quickest regulator granting approval of pharmaceuticals and medical devices.  Japan’s median approval time is 306 days for new active substances (NAS).   The Center for Innovation in Regulatory Science (CIRSI evaluated NDAs in ICH countries for NAS approvals.  According to CIRS approvals ranges from a high of 418 days for EMA, 343 days for FDA and 306 days for PMDA.  As noted by CIRS, FDA approval times increased for the first time in 5-years, and while PMDA had the shortest approval times this may have been influenced by the fact that 63% of the approvals had been prior approved by either EMA or FDA.  Is approval times a consideration in your launch strategy?