Share your views: Updates to Guidance for Lot Release Program for Schedule D (biologic) drugs
Current status: Closed
Opened on March 18, 2024, and was extended to May 16, 2024.
Health Canada is proposing to update the Lot Release Program. We have drafted a revised guidance document which reflects the changes.
Join in: how to participate
Send us an email
Send an email to brdd-cppic_brdd-cppci@hc-sc.gc.ca to receive the consultation documents and request a template to submit your comments.
Who is the focus of this consultation
The Government of Canada will engage with:
- stakeholders from the biologics industry
- regulatory affairs specialists
- foreign regulatory agencies
Key changes
Your ideas and input are sought around the changes we're proposing to the Guidance on Lot Release Program for schedule D (biologic) drugs. These changes include:
- replacing yearly biologic product reports with guidance about periodic quality reporting
- reducing the scope of Group 1A and Group 4 notifications to products derived from human plasma or those containing human-derived excipients
- replacing the term "faxback" with "notification"
Contact us
Centre for Policy, Pediatrics and International Collaboration
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Bldg #6, 100 Eglantine Drwy
Tunney's Pasture
Ottawa, ON K1A 0K9
Address Locator: 0601B
Email: brdd-cppic_brdd-cppci@hc-sc.gc.ca