Submission Guidelines

Changes, Updates and Reminders Related to CDR Guidelines   On Friday, June 9th, CADTH issued a CDR Update with a number of changes, updates, and reminders that are worth reviewing. The key highlights are: Two Process Changes Guidance for Subsequent Entry Non-Biological Complex Drugs Revised Documentation for Resubmissions Two Reminders (In-person CDR Meetings/Confidential Prices) Communication with Consultants Further detail, which has been drawn from the CDR Update, can be found…

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…