Canada’s regulatory approach to drugs for rare diseases: find drug reviews and decisions

From Health Canada

Find drug reviews and decisions

Anyone can find out if a submission has been accepted for review by Health Canada by searching the submissions under review list.

We publish Regulatory Decision Summaries (RDS). These summaries explain the purpose of the submission and the reason(s) for Health Canada’s decision on certain health products seeking market authorization. You can access RDSs through the Drug and Health Product Register.

Find a technical summary of the data that informed Health Canada’s decision

To give detailed explanations about why certain drugs and medical devices were authorized for sale in Canada, we publish Summary Basis of Decision (SBD) documents. The SBDs include regulatory, safety, effectiveness and quality (chemistry and manufacturing) considerations. You can access SBDs through the Drug and Health Product Register.

Find approved drugs and their approved usage

You can find specific information about drugs for rare diseases approved for use in Canada by accessing the Drug Product Database (DPD).

This database contains Health Canada authorized product monographs. We also publish Frequently Asked Questions: Product Monographs Posted to the Health Canada Website.

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