The Canadian Agency for Drugs and Technologies in Health (CADTH) revised its Guidelines for Manufacturers on Application Fees for the Common Drug Review. A draft version was circulated for stakeholder feedback in July, following which the below key changes were made:
- Fees for resubmission based on new clinical information were revised from $72,000 to $57,600
- Fees for resubmission based on new cost information only were revised from $36,000 to $7,000
- Fees for reviews of a product with multiple indications will be $72,000 for the first indication and $57,600 for additional indications, regardless of whether additional indications are filed at the time of initial submission or at a later date
- The refund for non-compliance with the 180 calendar day performance metric was changed from 10% to 25% of the application fee
|A||Submission for a new drug for review of a single indication
Submission for an existing drug for review of a new indication
Submission for a new combination product for review of a single indication
|B||Each subsequent new indication filed for review at the same time or sequentially for the application types listed in Schedule A
Resubmission based on new clinical information with or without new cost information
|C||Submission for a new combination product (funded components or CADTH designated tailored reviews)
Submission for a subsequent entry biologic
|D||Resubmission based on new cost information only
Request for a resubmission based on a reduced price during the embargo period
Request for reconsideration of an embargoed CDEC recommendation
New Submission Guidelines for the Common Drug Review
CADTH has published new Submission Guidelines for the Common Drug Review. Changes to Category 1 submission requirements include: a number of discontinued requirements, revisions to existing requirements, and new forms and templates. Details of these changes are highlighted in CDR Update – Issue 108. All changes to Category 2 submission requirements were previously announced in CDR Updates.
New Procedures for the Common Drug Review
CADTH has published new Procedures for the CADTH Common Drug Reviewas well. In addition to incorporating procedural changes previously announced in issues of CDR Update, this new version includes changes to terminology, forms and specific timelines, as highlighted in CDR Update – Issue 108.
For more information regarding the changes to the CDR submission guidelines, please see the CDR Update – Issue 108 on the CADTH website.