Posted by Michael Wonder on 08 Mar 2018
CADTH Common Drug Review will accept submissions up to six months pre-Notice of Compliance
8 March 2018 - Operational change can help reduce the time between regulatory approval and reimbursement recommendations for prescription drugs in Canada.
Today CADTH is pleased to announce an operational change to our Common Drug Review (CDR) program that will further align our health technology assessment process with Health Canada’s regulatory approval process for new prescription drugs in Canada.
In the CDR’s current process, a drug manufacturer can submit a drug for review up to three months (90 days) before it has been formally approved by Health Canada and received its Notice of Compliance (NOC) or Notice of Compliance with Conditions (NOC/c). Effective April 2, 2018, CADTH will now double this time horizon and accept drug submissions to the CDR up to six months (180 days) before the anticipated receipt of Health Canada’s NOC or NOC/c.
