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Q&A from the Cell Therapy Stakeholder Group Bilateral Meetings with Health Canada

Welcome to the regulatory Q&A hosted by CellCAN. Since 2014, stakeholders in the field of cell, tissue and gene therapies have been collaborating with Health Canada to keep the community informed and updated on regulatory considerations related to the fast and evolving field of regenerative medicine. The Cell Therapy Stakeholder Group (CTSG) convenes twice per year, addressing urgent matters and questions submitted by the scientific community at large.

Minutes from all meetings are available on our website. In order to make them easily searchable and accessible, the minutes have been transformed into an Q&A format below.

Note that although these answers are excerpts from approved minutes of meetings with Health Canada, this Q&A does not stand in any way, shape or form as an official statement from Health Canada and should never be used as an official source of regulatory insight.

Please inquire directly to Health Canada for follow-up questions.

The CTSG welcomes the addition of new members. To be part of the CTSG, please directly contact the BGTD Directorate at

Index of Questions

Q1 - When designing pre-clinical trials, should investigators use small or large animals? How many animals? What route of administration?

Q10 - Could Health Canada choose to re-classify a product after it has been regulated as a drug or device (e.g. if it undergoes changes in development)?

Q11 - Can minimally manipulated, autologous cells for homologous use be used under Practice of Medicine? For example, to heal sports injuries or for anti-aging therapies?

Q12 - Is there an exception to the definition of cell therapy products as drugs for same surgical procedures? Are there hospital exemptions?

Q2 - What are adequate numbers of animals and respective groups to ensure statistically and biologically robust interpretation?

Q3 - What type of preclinical data is required prior to approaching Health Canada for a pre-CTA meeting?

Q4 - Will my pre-CTA meeting interaction with Health Canada be held against me later in my clinical trial application (CTA)?

Q5 - Why do we need additional preclinical data when so much has been published already?

Q6 - What are common information gaps seen in clinical submissions?

Q7 - Under what circumstances does a clinical trial need to fill out an NSNR(O) Schedule 1 form? What triggers the NSN environmental assessment in addition to that performed in the CTA?

Q8 - What is the continuum of preclinical work that goes with Phase I/II/III – what needs to be done, when?

Q9 - Medical equipment is often used in cell manufacturing. Which manufacturing equipment will need to pass review as medical devices for manufacturing under the Medical Devices Bureau?

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