Health Canada Begins Phased Implementation of ICH Q12 and Q14: What Sponsors Should Know
This article examines Health Canada’s phased implementation of ICH Q12 and ICH Q14 and its implications for pharmaceutical quality, CMC development, analytical procedures, and post-approval change management in Canada. It explains the initial application of Post-Approval Change Management Protocols to biologic and Schedule C drugs regulated by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), clarifies that Established Conditions are not yet included, and outlines how sponsors can begin preparing for broader implementation. Introduction Health Canada has announced the interim implementation of ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, along with implementation of ICH Q14: Analytical Procedure Development. This…