title: Current practices and reform proposals for the regulation of advanced medicinal products in Canada.
abstract: We describe the Canadian regulatory framework for evaluating advanced medicinal products based on current policies, guidance documents and regulations and analyze proposed reforms. Our analysis is based on a documentary review supplemented by discussions with Health Canada officials. We present an overview of the Canadian regulatory framework for cell and gene therapy, medical devices and manufacturing facilities. We use the approval of Prochymal™ to highlight Canada's conditional marketing approval system. Finally, we discuss proposed changes to the regulatory framework in response to identified gaps, stakeholder consultations and international harmonization initiatives. Based on our analyses, we suggest that Canadian regulators have taken a reasonable approach in applying their regulatory framework without compromising on product safety.
authors.affiliation: Cell Therapy Program, University Health Network, Toronto, ON, Canada.|Institute of Biomaterials & Biomedical Engineering, University of Toronto, Toronto, ON, Canada.|Arthritis Program, University Health Network, Toronto, ON, Canada.|60 Leonard Avenue, Suite 3KD-462, Toronto, ON, M5T-2S8, Canada.
authors.forename: Sowmya
authors.initials: S
authors.lastname: Viswanathan
authors.affiliation: School of Public Health, University of Alberta, Edmonton, AB, Canada.
authors.forename: Tania
authors.initials: T
authors.lastname: Bubela
mesh_terms: D002170:Canada; D064987:Cell- and Tissue-Based Therapy; D003132:Commerce; D003663:Decision Trees; D017277:Drug Approval; D015316:Genetic Therapy / Q000331:legislation & jurisprudence; D040541:Marketing; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence*
keywords: Health Canada; accelerated market approval; advanced medicinal products; cell therapy; clinical trial; gene therapy; market approval; medical device; orphan drug framework; regulation; regulatory reform