Current practices and reform proposals for the regulation of advanced medicinal products in Canada

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Date: Aug. 2015
From: Regenerative Medicine(Vol. 10, Issue 5)
Publisher: Future Medicine Ltd.
Document Type: Report
Length: 11,285 words
Lexile Measure: 1710L

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Author(s): Sowmya Viswanathan [*] aff1 aff2 aff3 aff4 , Tania Bubela aff5

Keywords:

accelerated market approval; advanced medicinal products; cell therapy; clinical trial; gene therapy; Health Canada; market approval; medical device; orphan drug framework; regulation; regulatory reform

Regenerative medicine research and clinical translation has had a significant presence in Canada, extending as far back as 1961 when James Till and Ernest McCulloch pioneered the field of stem cell research with their publication of a method to quantify putative progenitor and stem cells [1 ]. Regenerative medicine research has been supported by multiple federal initiatives including the Stem Cell Network, funded from 2001 to 2016 by the Networks of Centers of Excellence (NCE) program, which has brought together researchers, bioengineers, clinicians and social scientists to move Canadian stem cell research to clinical application (Stem Cell Network, 2014). Now in its final 2 years of funding, the Network has left a strong legacy of research in Canada, and while the network did not directly fund clinical trials, clinical trials using stem cells and other cell types are ongoing across the country. As of April 2015, there are approximately 46 cell therapy clinical trials ongoing, enrolling or planned in Canada (Supplementary Table 1; see online at www.futuremedicine.com/doi/full/10.2217/RME.15.28); a further nine are completed and five were listed as terminated or unknown. Most trials (n = 33) are in cancers and most are early stage (Phases I, I/II or II); 11 are listed as Phase II/III or III but only three of these are underway.

Further support is provided by the Canadian Stem Cell Foundation, an independent, nonprofit charitable organization was founded in 2008 to fund and champion stem cell research in Canada. Further support for the clinical and commercial development of regenerative medicine comes from the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto, founded as a not-for-profit organization and supported by the Centers of Excellence for Commercialization and Research (CECR) program [2 ]. The most recent round of NCE funding has supported BioCanRx, which is focused on the clinical translation of novel cancer biotherapeutics, including immunotherapies and cancer vaccines and by the creation of CellCAN [3 ], a pan-Canadian network of cell manufacturing facilities aimed at accelerating cell-based clinical trials in Canada.

As these funding initiatives and strong research programs and networks have developed in Canada, novel therapeutic products are beginning to emerge clinically. It is therefore timely to consider the regulatory pathways for regenerative medicine products and other novel biotherapeutics (e.g., oncolytic viruses or antibodies in cancer therapies) in Canada. These are regulated as advanced medicinal products (AMPs) under the Food and Drug Act [ 4 ], primarily by Health Canada's Biologics and Genetic Therapies Directorate, which is responsible for the regulation of biological drugs for human use in Canada based on sound evidence of the product's quality, safety and efficacy. There are a number of regulations (Figure 1) that may apply to advanced medicinal products including the Food and Drug Regulations [5 ], Safety of Human Cells, Tissues and Organs (CTO) for Transplantation...

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Gale Document Number: GALE|A424015179