Health Canada Finalizes Regulatory Approval Process for Subsequent Entry Biologics - Tanya Weston

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On March 5, 2010 Heath Canada released its “Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics [“SEBs”][1] in order to enable sponsors to satisfy the information and regulatory requirements under the Food & Drugs Act and Regulations for the authorization of SEBs in Canada. The final guidance document has been the culmination of ongoing consultations since January 2008 resulting in the release of two prior draft documents. The final guidance document was released in conjunction with updated guidance documents relating to the Patented Medicines (Notice of Compliance) Regulations [“PM(NOC) Regulations”][2] and Data Protection under C.08.004.1 of the Food & Drug Regulations.[3]

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