Should New International Standards for Drug Packaging Safety Be Adopted?
Official title: Release of draft (step 2) ICH Guideline Q3E: Impurities: Guideline for Extractables and Leachables
Health Canada wants feedback on draft international guidelines for testing drug packaging materials. The guidelines address "extractables and leachables" - chemicals that can migrate from packaging into medications. This is part of a global effort to harmonize safety standards across countries.
Why This Matters
Ever wonder if your medication's packaging is safe? These guidelines help ensure chemicals from plastic containers, syringes, or inhalers don't contaminate your medicine. It's technical stuff, but it affects every pill bottle and injection device you use.
What Could Change
Drug manufacturers would need to follow standardized testing protocols for packaging materials. This could streamline approvals for new medications across Canada, the US, Europe, and Japan. Companies already meeting these standards would face less regulatory burden.
Key Issues
- Are the proposed testing methods for extractables and leachables appropriate?
- Do the guidelines adequately address drug delivery device components like syringes and inhalers?
How to Participate
- Download the ICH template for public consultations to format your comments.
- Review the draft Q3E guideline on extractables and leachables on the ICH website.
- Submit your completed comments to ich@hc-sc.gc.ca by January 14, 2026.