Guidance document on submission information for biologic drugs (Division 4, Schedule D)​Health Canada RSS – Drug Products, Drugs and Health Products

Written by donkafader2

 Health Canada is modernizing regulations that apply to biologic drugs by replacing an outdated Division 4 with regulations that align more closely with modern science and current practice. The new Division 4, a component of Agile Licensing that was published on December 18, 2024, comes into force on July 1, 2025.

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