How to Demonstrate Foreign Building Compliance with Good Manufacturing Practices

Health Canada Issues comprehensive guidance on how to demonstrate GMP compliance for foreign establishments under a Canadian Drug Establishment License (DEL). It clearly outlines the scope (fabrication, packaging, labeling, testing) and the types of drug products covered, which greatly aids importers in understanding their obligations under Part C, Division 2 of the Food and Drug Regulations.

Importantly, this document emphasizes the importer’s responsibility to ensure that any foreign facility involved in drug manufacturing or testing meets Canadian GMP standards—and explains what evidence must be submitted and how DEL applications should be updated. The clarity around activities that are—and are not—within scope (for instance, clinical trials, medical devices, and excipients) helps avoid confusion and streamline compliance efforts.

This resource is an invaluable tool for stakeholders looking to align with Health Canada’s regulatory expectations, and I encourage all DEL holders and importers to review it carefully when managing foreign manufacturing sites.

For more detailed information, you can read the document from Health Canada here: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)