Regulatory Decision Summaries

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.

Regulatory Decision Summary Documents

RDSs for pharmaceuticals, biologics, and medical devices are now available exclusively on the website through the Drug and Health Product Register (DHPR). Click here to access the RDS search function in the DHPR. Searches can be conducted by manufacturer, medicinal ingredient, drug or device name, drug identification number, or device licence number.

When a Summary Basis of Decision (SBD) is published, a link to the SBD will be included within the applicable RDS.

Phased Approach to Regulatory Decision Summaries

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:

  • Positive decisions for new drug submissions (NDSs) (prescription pharmaceuticals and biologics)
  • Positive decisions for supplemental new drug submissions (SNDSs) for new uses (prescription pharmaceuticals and biologics)
  • Positive decisions for new class IV licence applications (medical devices)

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 are posted for final negative decisions and cancellations for:

  • NDSs,
  • SNDSs for new uses, and
  • new class IV medical device applications.

For more information, contact the Office of Planning, Performance and Review Services.

External Consultation Report 2016

The purpose of this report is to provide a summary of the results of the on-line questionnaire. The subject of the questionnaire was health product transparency initiatives.

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