Share your views: New Annex 13 to the Good manufacturing practices guide for drugs used in clinical trials (GUI-0036)
From: Health Canada
Current status: Open
Opened on March 21, 2024, and will close to new input on May 21, 2024.
This revised guidance document contains new information. The information is being adapted from the following Pharmaceutical Inspection Cooperation Scheme (PIC/S) document:
- Annex 13: Guide to good manufacturing practices for medicinal products annexes: Manufacture of investigational medicinal products
Join in: how to participate
Send an email to hpil-consultation-ipsop@hc-sc.gc.ca to ask for the consultation package and submit your comments by May 21, 2024. We will consider all comments when we finalize the guidance document.
Focus of this consultation
Health Canada is adapting this annex to align our compliance standards with the international good manufacturing practice standards. As an active participating member of PIC/S, we will continue to update this guidance to align it with their standards.
This guide is an annex to the following Health Canada guidance document:
GUI-0001 and annex 13 are to be read together. They will help you understand and comply with:
- Part C, Division 2, of the Food and Drug Regulations
- which is about good manufacturing practices
- relevant sections of Part C, Division 5
- which is about drugs for clinical trials
Key changes in the draft guidance
We edited the draft guidance document to make it easier to understand.
We have also made changes in several sections to make the meaning clearer. For example:
- decreased record retention period for all records to align with regulation updates
- added references to relevant sections of C.05 of the regulations
- for example, C.05.012 is now included in the documentation section
- added shipping details in the section on release of batches
Contact us
Health Product Compliance Directorate (HPCD)
13th Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney's Pasture
Ottawa ON K1A 0K9
Email: drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca