June 21, 2017
Pangaea Express - INESSS update
by Marla Weingarten, Consultant
Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) has released new submission guidelines and has implemented a pre-NOC review process – starting immediately.
INESSS will evaluate certain drug products* before a Notice of Compliance (NOC) from Health Canada has been issued. For drugs meeting the criteria, manufacturers will now be able to submit to INESSS:
- 180 days pre-NOC for oncology drugs
- 90 days pre-NOC for any other drugs
*Criteria for early submission to INESSS:
- Medications intended to treat a serious health problem
- Evidence suggesting the drug significantly improves patients' health compared to the treatment options currently listed on either the General Drug List or the Drug List - Establishments or available through specific funding from the Ministry of Health and Social Services
The difference between CADTH and INESSS:
- CADTH – enforces a 120 pre-NOC submission for all products
- INESSS – 90 day pre-NOC submission (180 oncology) BUT this is only for certain drugs as described above and is not actually mandatory
The new guidelines, Guide de soumission d’une demande à l’INESSS, identify specific requirements (outlined in individual submission forms) depending on the type of submission provided to INESSS, i.e. a new innovative drug, a new indication, pre, or post-NOC, a new pharmaceutical form, a new biosimilar drug or new biosimilar indication, new multisource drug etc.
For more information please contact Marla Weingarten, Consultant, The Pangaea GroupTweet