Share your views: Updates to Guidance for Lot Release Program for Schedule D (biologic) drugs

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