The regulatory body for approval of medicines in Canada is the Therapeutic Products Directorate of Health Canada.
Health Canada develops and enforces regulations under Canadian governmental legislation.
Health Canada applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality. Health Canada finalised guidelines for biosimilars or subsequent entry biologics (SEBs) as they call them in March 2010. The objective of the guidance is to enable sponsors to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations for the authorisation of SEBs in Canada. 1. Specific Guidelines 2. Accompanying Guidance Publication of Updates to Guidance Document: Patented Medicines (Notice of Compliance) Regulations Questions and Answers to Accompany the Final Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) Submission requirements for SEBs are determined by Health Canada on a case by case basis, and may include, but not be limited to:
These guidelines are specific to the type of biosimilar product:
Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)
Date: 5 March 2010
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php
Publication of Updates to Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations
Date: 8 March 2010
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/data_donnees_protection-eng.php
Date: 8 March 2010
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3-eng.php
Date: 27 May 2010
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/01-2010-seb-pbu-qa-qr-eng.php
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