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:

Join in: how to participate

Send an email to 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:

Key changes in the draft guidance

We edited the draft guidance document to make it easier to understand.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:

Contact us

Health Product Compliance Directorate (HPCD)
13th Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney's Pasture
Ottawa ON  K1A 0K9

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