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

@article{Viswanathan2015CurrentPA,
  title={Current practices and reform proposals for the regulation of advanced medicinal products in Canada.},
  author={Sowmya Viswanathan and Tania M Bubela},
  journal={Regenerative medicine},
  year={2015},
  volume={10 5},
  pages={647-63}
}
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… CONTINUE READING