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Regulatory roadmap for biologic (Schedule D) drugs in Canada - Canada.ca

Apr 18, 2025

legacy-hc-2025-04-21

ID 250182

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Regulatory roadmap for biologic (Schedule D) drugs in Canada - Canada.ca

Jan 2, 2026

hc-20260101

ID 428833

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updated3 sections changed
3 sections changed0 added0 removed+3 / -6 linesChange ratio: 1%
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+++
@@ -1,6 +1,4 @@
Regulatory roadmap for biologic (Schedule D) drugs in Canada
-From:
-Health Canada
This regulatory roadmap gives comprehensive, general information about the regulation of biologic drugs for human use in Canada.
All drugs that are marketed in Canada are subject to the Food and Drugs Act and Regulations.
The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) reviews and provides market authorization of all drug submissions for biologic drugs for human use. Market authorization by Health Canada is required before a biologic drug can be sold in Canada.
@@ -285,9 +283,9 @@
Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs
for information on the lot release program.
Risk Management Plan
-Sponsors should submit a Risk Management Plan as part of their drug submission for a biologic 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 biologic drug.
Labelling
The BRDD reviews the labels for biologic drugs. This includes:
package inserts
@@ -481,5 +479,4 @@
Regulation of Medicinal Maggots and Medicinal Leeches
Fecal Microbiota Therapy Used in the Treatment of Clostridium difficile Infection Not Responsive to Conventional Therapies
Page details
-Date modified:
2024-06-04