Consultation on draft Guidance for Sponsors: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans

Notice to the reader:

The online consultation is now closed. The final guidance is available now.

Health Canada is pleased to announce the above referenced draft guidance for a 60 day comment period; October 7, 2014 to December 6, 2014. The guidance document is being developed to meet current needs of cell therapy clinical trial sponsors. An electronic copy of the draft guidance can be obtained by emailing at request to Health Canada at

How to Get Involved

This notice requests comments on the document that will be considered before finalising the guidance document.

Comments should be provided to Health Canada by December 3, 2014, in order to allow sufficient time for their assessment and inclusion in the final document.

Contact Information

Office of Policy and International Collaboration,
Biologics and Genetic Therapies Directorate,
Health Products and Food Branch
Health Canada
100 Eglantine Driveway
Ottawa ON
K1A 0K9
AL 0601B

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