Regulatory Decision Summaries (RDSs) explain Health Canada's decision for certain health products seeking market authorization.
The RDSs include the purpose of the submission and the reason for the decision.
These pages also include summaries of certain submissions that were accepted into review and subsequently cancelled by the sponsor.
The RDSs are organized alphabetically for drugs (prescription pharmaceuticals and biologics) and medical devices for human use.
When a Summary Basis of Decision (SBD) is published, a link to the SBD will be included within the applicable RDS.
You can find more information about the phased approach in the Notice: Regulatory Decision Summaries and the Submissions Under Review List.
For decisions issued after April 1, 2015, RDSs are posted for:
For submissions accepted into review after April 1, 2015, summaries are posted for final negative decisions and cancellations for NDSs for new active substances (pharmaceuticals and biologics). New active substances contain a medicinal ingredient not previously approved in a drug in Canada (and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate, or polymorph).
For submissions accepted into review after May 1, 2016, summaries will also be posted for final negative decisions and cancellations for:
For more information, contact the Office of Planning, Performance and Review Services.