March 5, 2010
Our file number: 10-10569-330
Health Canada is pleased to announce the release of the finalized Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs).
The objective of this document 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 subsequent entry biologics (SEBs) in Canada.
Two draft versions of this guidance document have been shared for consultation purposes on February 27, 2008, and March 27, 2009. Consultation Reports are available upon request to the address below. As no transition period is required, the guidance will be effective on the date of publication.
Note: The "Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)" is being published concurrently with the following documents.
Special Projects Unit,
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Address Locator 0702A
200 Tunney's Pasture Driveway
Ottawa ON, K1A 0L2