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 prescription drugs (pharmaceuticals and biologics) and medical devices are now available exclusively on the Canada.ca 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
For decisions issued on or 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 on or after April 1, 2015, summaries are posted for final negative decisions and cancellations for NDSs for new active substances (prescription 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 on or after May 1, 2016, summaries are posted for final negative decisions and cancellations for:
- NDSs for prescription pharmaceuticals and biologics,
- SNDSs for new uses for prescription pharmaceuticals and biologics, and
- new class IV medical device applications.
RDSs are posted for final positive decisions issued on or after October 1, 2018 for SNDSs for prescription pharmaceuticals and biologics, specifically:
- new routes of administration,
- new dosage forms, and
- new strengths.
RDSs are also posted for final positive and negative decisions on Abbreviated New Drug Submissions (ANDSs) and their supplements (SANDSs) for prescription pharmaceuticals and biologics that Health Canada decides might be of interest to stakeholders. Possible examples of eligible submissions/decisions could include the following:
- Where Health Canada significantly deviates from its published guidance documents,
- Critical dose drugs, and
- Complex drug substances and/or drug products.
Decisions in scope are as follows:
- final positive decisions issued on or after October 1, 2018 for ANDSs and SANDSs that might be of interest to stakeholders, and
- final negative decisions for ANDSs and SANDSs that might be of interest to stakeholders and were accepted into review on or after October 1, 2018.
For more information on the implementation of Phase III, please see the Notice published in August 2018.
Several external consultations have been held as the RDS initiative has evolved. In 2017, an external consultation was held on five transparency proposals for prescription drugs. This report provides a summary of the consultation results.
The purpose of this report is to provide a summary of the results of the on-line questionnaire posted in 2016. The subject of the questionnaire was health product transparency initiatives.
For more information, contact the For more information, contact the Office of Planning, Performance and Review Services.
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