Abstract
In Canada, minimally manipulated autologous cell therapies for homologous use (MMAC-H)
are either regulated under the practice of medicine, or as drugs or devices under
the Food and Drugs Act, Food and Drug Regulations (F&DR) or Medical Device Regulations
(MDR). Cells, Tissues and Organs (CTO) Regulations in Canada are restricted to minimally
manipulated allogeneic products for homologous use. This leaves an important gap in
the interpretation of existing regulations. The purposes of this workshop co-organized
by the Stem Cell Network and the Centre for Commercialization of Regenerative Medicine
(CCRM) were to discuss the current state of regulation of MMAC-H therapies in Canada
and compare it with other regulatory jurisdictions, with the intent of providing specific
policy recommendations to Health Canada. Participants came to a consensus on the need
for well-defined common terminology between regulators and stakeholders, a common
source of confusion and misinformation. A need for a harmonized national approach
to oversight of facilities providing MMAC-H therapies based on existing standards,
such as Canadian Standards Association (CSA), was also voiced. Facilities providing
MMAC-H therapies should also participate in collection of long-term data to ensure
patient safety and efficacy of therapies. Harmonization across provinces of the procedures
and practices involving administration of MMAC-H would be preferred. Participants
felt that devices used to process MMAC-H are adequately regulated under existing MDR.
Overly prescriptive regulation will stifle innovation, whereas insufficient regulation
might allow unsafe or ineffective therapies to be offered. Until a clear, balanced
and explicit approach is articulated, regulatory uncertainty remains a barrier.
Key Words
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Article info
Publication history
Published online: September 27, 2017
Accepted:
August 20,
2017
Received:
May 29,
2017
Identification
Copyright
© 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.
