Consultation opens for Annex 13 to the Good manufacturing practices guide for drugs used in clinical trials (GUI-0036)
Drug Establishment Licensing Bulletin 164, March 21, 2024
On this page
About the consultation
Health Canada is seeking feedback from stakeholders on the new Annex 13 to the Good manufacturing practices guide for drugs used in clinical trials (GUI-0036). The consultation period is for 60 days and runs from March 21 to May 21, 2024:
- share your views on the new Annex 13 to the Good manufacturing practices guide for drugs used in clinical trials
This guide contains new information. GUI-0036 is also adapted from the international document titled Annex 13: Guide to good manufacturing practices for medicinal products annexes: Manufacture of investigational medicinal products.
Health Canada is working to harmonize compliance standards with the international standards by adapting this annex. We're an active participating member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). We will continue to update this guidance to align it with the good manufacturing practice 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 (regulations)
- which is about good manufacturing practices
- relevant sections of Part C, Division 5
- which is about drugs for clinical trials
Overview of key changes
We edited the draft guide to make it easier to understand.
We 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
We also added a reference section listing references on clinical trials that are not available in GUI-0001, along with their urls.
How to participate
Email us to request the consultation package and submit your comments by May 21, 2024. We will consider all comments when we finalize the guidance document.