CHP Canada Submits Members Comments on Quality Guidelines for Division 8 Products
Health Canada released a series of guidance documents for consultation in November 2016. We sent our submission to provide further comment on the quality requirements for Division 8 drugs. Consultation documents included:
• Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS)
• Addendum – Questions & Answers
• Glossary of Terms
• Certified Product Information Document and template
Our Product Quality Sub-Committee discussed changes and determined issues for review, as well proposed industry solutions to Health Canada. Although both prescription drugs and OTCs are currently in scope of these revised guidances, we have taken the opportunity to advocate for appropriate chemistry and manufacturing requirements for self-care products under the self-care framework.
We indicated to Health Canada that we would like certain elements of the original 2013 document to remain, including retroactive implementation, and that we would like increased clarity within wording on quality testing.
We are pleased that the Bureau of Pharmaceutical Sciences at the Therapeutic Products Directorate has accepted our submission. We look forward to the result of this consultation.