Health Canada Issues Revised Post-marketing Quality Change Guidance
Health Canada has issued revised guidance concerning post-marketing quality changes that clarifies the categorization, criteria and application requirements for such changes.
The revised guidance, published 15 October 2013, applies to sponsors intending to make changes to new drugs that have received a Notice of Compliance (NOC). Product types may include pharmaceuticals, biologics and radiopharmaceuticals for human use and pharmaceutical, radiopharmaceutical and certain biotechnological products for veterinary use.
It also applies to those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.
The principles established in the guidance also intended to be applied to similar quality changes that occur during the development of a new drug, and the recommended supporting data should be included with the initial New Drug Submission (NDS) or Abbreviated New Drug Submission (ANDS).