Back From CHFA Quebec And Regulatory Update

Posted by on Feb 6, 2013 in Latest News | 0 comments

Eugene Martynovitch, our VP Business Development and Quality, attended the Regulatory Breakfast preceding the CHFA trade show in Montreal last week. Main updates from the NHPD were:

– There will be an 18-month transition periodĀ from UPLAR to regular licensing.
– Enforcement measures will be assessed on the basis of potential risk to the public.
– A 3-class PLA review system is being implemented, where Class 1 includes low risk, high certainty products (such as those with Pre-Cleared Information (PCI) – and that is 75% of all license applications anyway). The review timeframe target for this category is an unbelieveable 10 days! NHPD insists that this is a realistic target for the near future.
– NHPD’s end goal is to create high predictability of license application outcomes and timeframes.

There was a lot more said in the presentations and in the Q&A period.

Please join us for future events.