Reply To: Importing Gene Therapy IP into Canada

[Anonymous]

Reply To: Importing Gene Therapy IP into Canada

Thank you for your inquiry, as the Cell and Gene Therapy E-Team have reached out to industry experts with knowledge on the regulatory aspects of your request.

We have broken our response into two parts and have assumed your question is related to a clinical trial:

Part 1: Non-Resident Importer Program:
This refer to business that wish to export material to Canada where they don’t have a local business entity, in this case there is an option to apply for non-resident Business number.
This section refer to business tax arrangements in Canada and does not cover any possible additional Health Canada compliance requirements for sponsor obligations; please see below publication and procedures:

Link: https://www.trade.gov/canada-non-resident-importer-program

Part 2: Health Canada Responsible party:
We think your question likely refers to the biological risks, which we discuss further below:

There are several Health Canada Regulations related to cell gene therapy manipulations risk to the biological component in the therapy, therefore the study sponsor may be subject to specific conditions that would depend on the cell manipulation, manufacturing procedures, patient risks and safeguards.

The study sponsor would need to have been granted clinical trial authorization in Canada, and if so, the study sponsor would need to have a Health Canada No Objection Letter.

Additional Supporting Information:

Health Canada Policy Position Paper – Autologous Cell Therapy Products:
Link: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/cell-therapy-policy.html

Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans
Link: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/guidance-document-preparation-clinical-trial-applications-use-cell-therapy-products-humans.html

Scott Ohanesian
GCSG CGT e-Team Lead