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Regulatory roadmap for radiopharmaceutical (Schedule C) drugs in Canada - Canada.ca

Apr 18, 2025

legacy-hc-2025-04-21

ID 249954

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Later capture

Regulatory roadmap for radiopharmaceutical (Schedule C) drugs in Canada - Canada.ca

Jan 2, 2026

hc-20260101

ID 428832

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updated2 sections changed
2 sections changed0 added0 removed+3 / -4 linesChange ratio: 1%
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+++
@@ -192,9 +192,9 @@
Support Canadians' timely access to safe, efficacious and high quality drugs
Support ongoing evaluation of information that could have an impact on the benefit-risk profile of health products, and
Align drug vigilance with international best practices
-Sponsors should submit a Risk Management Plan as part of their drug submission for a radiopharmaceutical drug. The
-Guidance Document on Submission of Risk Management Plans and Follow-up Commitments
-has more information.
+Sponsors should consult the
+Submitting Risk Management Plans Guidance Document
+for information on when to submit a risk management plan with their drug submission for a radiopharmaceutical drug.
Labelling
The label and package are the first points of interaction between a health product and a healthcare professional or patient. It is essential that all labelling and packaging regulatory requirements be met. In order to ensure these requirements are met, the BGTD reviews all labels for radiopharmaceutical drugs according to the specific labelling regulations found in Division 3 of the
Food and Drug Regulations
@@ -400,5 +400,4 @@
Improving the regulatory review of drugs and devices
Forms - Applications and submissions
Page details
-Date modified:
2024-05-08