Should Canada Adopt New International Standards for Chemical Safety in Drug Packaging?
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 chemicals that can leach from drug packaging into medications. These rules would standardize how pharmaceutical companies check whether plastic containers, rubber stoppers, or delivery devices release harmful substances into the drugs they hold.
Why This Matters
Ever wonder what's in your pill bottle besides the pills? Chemicals from packaging can leach into medications over time. These guidelines aim to ensure the plastic, rubber, and other materials touching your medicine are properly tested for safety.
What Could Change
If adopted, pharmaceutical companies would need to follow standardized international testing protocols for packaging materials. This could affect how drugs are packaged and may require reformulation of some products. The guidelines would apply to all drug delivery device components.
Key Issues
- Are the proposed testing requirements for extractables and leachables appropriate?
- Do the guidelines adequately address drug delivery device components?
How to Participate
- Download and use the ICH template for public consultations to format your comments.
- Submit your comments by email to ich@hc-sc.gc.ca before the deadline.
Submit Your Input
Tips for Your Submission
- Use the ICH template for public consultations to format your comments
- Comments will be transmitted to ICH as provided