Notice of publication: Annex 13 to the good manufacturing practices guide for drugs used in clinical trials (GUI-0036)
Drug Establishment Licensing Bulletin 189, February 4, 2026
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About the publication
On February 4, 2026, Health Canada published the following guidance document:
This document takes effect immediately.
The updated guidance document follows a 60-day consultation period that took place March 21 to May 21, 2024. We reviewed the feedback from stakeholders and implemented changes where applicable.
Learn more:
This guidance document is adapted from the following Pharmaceutical Inspection Cooperation Scheme document:
As an active participating PIC/S member, Health Canada is aligning with international harmonisation of compliance standards by adapting these annexes.
This guide is an annex to the following Health Canada guidance document:
These guides are to be read together. They will help you understand and comply with:
- Part C, Division 2, of the Food and Drug Regulations (FDRs), which is about good manufacturing practices
- Relevant sections of Part C, Division 5, which is about drugs for clinical trials
Overview of key changes
This revised guidance document contains new information to make the document clearer and align with current industry practices.
We made changes to the following:
- Added guidance on Health Canada’s requirements on sample retention
- Included additional information clarifying labeling requirements
- Updated wording to reflect current Clinical Trial processes
- Provided additional guidance on product recall
- Language and formatting updates
How to contact us
If you have any questions, we invite you to contact the Health Product Inspection and Licensing Division (HPIL) of the Regulatory Operations and Enforcement Branch (ROEB).