Regulatory Focus™ > News Articles > Health Canada Overhauls Product Monograph Guidance

Health Canada Overhauls Product Monograph Guidance

Posted 07 April 2014 | By Louise Zornoza

Health Canada issued revised product monograph guidance on 4 April 2014 that sets forth new design and format requirements, and also includes a new section on preparing patient information.

According to Health Canada, the changes are intended to emphasize clinical relevance, make information easier to retrieve and provide format and information consistency across different drugs and drug classes.

The revisions also include specific guidance for the following drug groups:

  • a product that has been granted a notice of compliance with conditions
  • a subsequent entry (bioequivalent) product
  • a Schedule C (radiopharmaceutical) product
  • a Schedule D (biological) product

Product monographs provide information for the safe and effective use of a new drug and also set the standard for drug promotion and advertising.


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