Submission Fees
Author: Patrick Manfred, Vice-President, TACT Conseil, Quebec Market Access Expert Date: June 2, 2021 A proposal to modify the current regulation framing the fees payable to the Institut national d'excellence en santé (INESSS) to complete a scientific evaluation of a drug and/or a stable blood product was published in Part 2 of the Quebec Official Gazette, on March 18, 2021. If the Quebec government does not deviate from…
INESSS Introduces New Pre-NOC and Biosimilar Guidance The Institut national d'excellence en santé et en services sociaux (INESSS) released its new submission guidelines on June 2nd, 2017. The guidelines, which are now effective, include revised and new Form applications and letter templates for drug submissions. The two major highlights relate to pre-NOC review and the introduction of new guidelines for biosimilar submissions. Pre-NOC Review Unlike the CADTH pre-NOC guidelines…
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