Consultation on the revised Guidance Document: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)
December 7, 2015
Notice to Stakeholders
Health Canada is pleased to release a draft version of the revised Guidance Document: Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance) for consultation. The objective of the SEB Guidance is to provide guidance to sponsors to enable them to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations for the authorization of SEBs in Canada.
Revisions to the SEB Guidance are based on Health Canada's experiences over the past five years as well as international developments in the regulation of SEBs.
Key revisions to the SEB Guidance include:
- Section 2.1.3, Reference Biologic Drug: Further guidance is provided with respect to considerations in the selection of a reference biologic drug. This also includes revisions to Section 220.127.116.11 Considerations for the use of a non-Canadian reference biologic drug, to provide clarity on establishing a link between the non-Canadian reference and Canadian reference biologic drug.
- Section 2.3.3, Non-Clinical and Clinical Information: Additional detail is provided with respect to considerations when performing non-clinical and clinical studies for SEBs, including discussion with respect to immunogenicity, the use of the most sensitive population in clinical trial design and a new section on extrapolation.
- Section 2.4, Post-Market Requirements: Updated information with respect to periodic benefit-risk evaluation reports (PBRERs) and labelling changes for product class type-specific safety information, including Health Canada's considerations in the review of a Supplemental New Drug Submission (SNDS) and the use of previously demonstrated similarity provided in the original New Drug Submission (NDS) to support a change.
- Section 3.0, Consultation with the Biologics and Genetic Therapies Directorate: A new section which promotes early consultation with Health Canada, as well as the launch of three year pilot for SEB Scientific Advice Meetings to allow for discussion of an SEB with Health Canada early in the development process.
How to Get Involved
This consultation is open for comment until February 15, 2016. Please select and read through the link below titled "consultation document." Interested parties are invited to email comments to BGTD.OPIC@hc-sc.gc.ca using the template provided. Comments will also be accepted by fax or by mail. All comments will be considered in the finalization of the document.
For your convenience, please find attached a template for your comments.
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Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate, Health Products and Food Branch
Building #6, 100 Eglantine Driveway
Ottawa, ON K1A 0K9
Address Locator: 0601B