Frequently Asked Questions - Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs

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Frequently Asked Questions - Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs (PDF Version, 57 Kb)
Date: 2005-05-26

1. Why does BGTD have a Lot Release Program?

Since biologic drugs are isolated from, or manufactured using, living organisms, they are inherently more variable than chemically synthesized drugs and require additional regulatory oversight. Biologic drugs are sensitive to changes in the starting materials and manufacturing, and therefore difficult to consistently produce and characterize. The Lot Release Program provides an additional check on biologic drugs to help assure their safety for human use. The program is risk-based; the degree of regulatory oversight corresponds to the level of risk associated with the drug.

2. Which document does the updated Lot Release Guidance Document supercede?

The updated Guidance supercedes the draft Review/Testing/Approval of Biologic Drug Lots document that was released in 1996. The old document and its appendices have been removed from the BGTD website.

3. What changes have been introduced in this updated Guidance Document?

The following changes have been made within the document:

• Sponsors must submit a Yearly Biologic Product Report for all approved biologic drugs.
• The Fax-back process for Group 4 products is being expanded to include all Group 4 products, not just those containing Human-derived Excipients (HDE).
• The Fax-back forms for Group 4 Products and Clinical Trial Materials have been updated.
• Factors considered for the assignment of products to Evaluation Groups have been revised to improve clarity and transparency.

4. Why is the Fax-back Process being expanded to include all Group 4 products?

BGTD currently receives minimal information on Group 4 products. Expanding the application of the Fax-back process to all Group 4 products, rather than only those that contain HDE, will provide BGTD with rapid access to information on Group 4 products that are being distributed onto the Canadian market. This information will be used for risk management purposes.

5. What is the effective date for this Guidance Document?

This Guidance document is effective as of June 1, 2005.

The following phased-in approach is being used to implement key changes:

• Effective June 1, 2006, Sponsors are to begin submitting YBPRs to BGTD.
• Effective June 1, 2006, the Fax-back process will apply to all Group 4 products. Until then, the Fax-back process for Group 4 products continues to apply only to those products that contain HDE. The appropriate Fax-back forms provided in Appendices IB and IC should be used by sponsors.

6. How will the Yearly Biologic Product Report (YBPR) be used?

The information from the YBPR could be used to assess the ongoing safety and quality of the product, to verify the consistency of the process, and to highlight any trends. BGTD will review the YBPR and, where appropriate, notify sponsors of changes in the assignment of the Evaluation Group.

7. Will BGTD accept annual product reports prepared for other regulatory authorities in lieu of the YBPR?

A report prepared for another regulatory authority will be accepted if it contains the information outlined in Section 5.1.1 of the Guidance document.

8. What types of changes to raw materials should be reported in the YBPR?

Sponsors should submit a list of changes to raw material suppliers as well as a list of changes to non-compendial specifications. Reporting these changes in the YBPR does not replace other reporting requirements related to changes to raw materials.

9. Is the submission date for the YBPR flexible?

Yes, the date of first submission of the YBPR may be negotiated with BGTD so that it coincides with the submission of a similar report to another regulatory authority. The sponsor should inform BGTD when the first YBPR will be submitted, after which subsequent reports should be submitted every 12 months. Alternatively, the YBPR can be submitted as an addendum to the Annual Drug Notification Report no later than October of each year. Sponsors should begin submitting YBPRs as of June 1, 2006.

10. Is a YBPR required for each DIN or can similar products (e.g. different strengths) be grouped together?

For ease of preparation and of review, scientifically justified groupings may be submitted as one YBPR. Questions regarding groupings should be forwarded to the Regulatory Affairs Division in BGTD.

11. How do I submit the YBPR?

An electronic PDF version and paper copy of the YBPR should be submitted. Alternatively, duplicate paper copies of the report may be submitted.

The YBPR can be submitted as an addendum to the Annual Drug Notification Report or it can be submitted directly to the Regulatory Affairs Division at the following address:

Regulatory Affairs Division
Centre for Policy and Regulatory Affairs
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
1st Floor, Building #7, Address Locator: 0701A
Tunney's Pasture
Ottawa, Ontario K1A 0L2

12. What if I have a DIN, but my product is not being manufactured or sold?

A YBPR is required for all Schedule D (Biologic) Drugs regulated by BGTD. If no lots are manufactured or sold within the reporting year, the sponsor should submit the YBPR indicating this.

13. Does a lot failure include a lot that failed based on release requirements of another competent regulator - if those requirements are different from the Canadian requirements?

The standard for lot failure is as defined in the Guidance document. Thus all lots which fail, as per the definition, should be reported by the sponsor irrespective of whether they were distributed in Canada or internationally.