Product License Failure Rate

Is the Product License Failure Rate Over 60% ?

It is difficult to verify the actual numbers as the NHPD publications concerning the status of submissions are not clear. For example, from the last publication covering the period from November 2006 to November 2007 we learn that there were 11,302 product license applications processed. Of these 4,334 received licenses and 6,368 failed. This is 56% failure rate. However, the same publication shows that there were 1,023 applications that involved the transition for products that had Drug Identification Numbers (?DINs?) to NHP Licenses. Because these products were already deemed safe and effective by Health Canada (which is why they received DINs), it can safely be assumed that most if not all of them received NHP licenses. If this figure is part of the total applications processed, then the failure rate for license applications for non-DIN products is 62% for this one year period.

The statistics for September 2006 to September 2007, are similar. There is a 59% failure rate including DIN products and a 62% failure rate for non-DIN products.

For the period from January 1, 2006 to July 2006, there was a 65% failure rate for all product license applications.

There are no published figures for August 2006, or for prior to January 2006.

product licenses