Current practices and reform proposals for the regulation of advanced medicinal products in Canada
Document Type
Review Article
Department
Office of the Provost
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.
Publication (Name of Journal)
Regenerative Medicine
DOI
10.2217/rme.15.28
Recommended Citation
Viswanatha, S.,
Bubela, T. M.
(2015). Current practices and reform proposals for the regulation of advanced medicinal products in Canada. Regenerative Medicine, 10(5), 647-663.
Available at:
https://ecommons.aku.edu/provost_office/766
Comments
This work was published before Tania joined Aga Khan University.