CADTH issues draft guidelines for manufacturers on application fees for the CADTH Common Drug Review

CADTH

As communicated on May 13, 2014, effective September 1, 2014, CADTH will be introducing an industry application fee for submissions and resubmissions filed by drug manufacturers for review under the Common Drug Review process.

The fee will supplement existing federal, provincial, and territorial funding and will be used to help finance an increase in the number of drugs we review annually. All CADTH Common Drug Review submissions and resubmissions for drugs that receive a Health Canada Notice of Compliance or Notice of Compliance with conditions on or after September 1, 2014 will be subject to the fee.

CADTH is pleased to invite all interested parties to provide feedback on the draft Guidelines for Manufacturers on Application Fees for the CADTH Common Drug Review. These draft guidelines have incorporated initial feedback received from the industry association groups (Rx&D and BIOTECanada).

The feedback period is now open. Please note that this will be the only opportunity to provide feedback on this document. The deadline to submit feedback is Friday, August 15, 2014.

For more details, go to: http://www.cadth.ca/en/feedback/cdr-fees

Michael Wonder

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Michael Wonder

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