Regulatory decision summaries of drugs and health products

Understand the decisions to approve or not approve the sale of drugs and medical devices in Canada. The reasons for these decisions are in the regulatory decision summaries (RDSs).

RDSs are posted for positive decisions issued after April 1, 2015, for:

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

Summaries are also posted for negative decisions and cancellations for NDSs accepted into review after April 1, 2015. These submissions are for drugs containing new active substances, pharmaceuticals and biologics with an active ingredient not approved in Canada.

For submissions accepted into review after May 1, 2016, RDSs will be posted for negative decisions and cancellations for:

  • NDSs
  • SNDs for new uses
  • new class IV licence applications for medical devices

RDSs are being implemented in a phased approach.

View the Regulatory Decision Summaries

If you have further questions, please email OPPRS_enquiries@hc-sc.gc.ca.

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