Policy Review: Addressing the Complex Challenges of Regulating Biotherapeutics

Authors

  • FengYun Li University of Calgary
  • Shalpinder Dhothar University of Calgary
  • Elena Fekete University of Calgary
  • Nishi Patel University of Calgary
  • Tiffany Dang University of Calgary
  • Rachelle Varga University of Calgary
  • Syed Jafri University of Calgary
  • Neliza Mendoza University of Calgary
  • Siddhartha Goutam University of Calgary
  • Nilesh Sharma University of Calgary
  • Noshin Karim University of Calgary
  • Nicholas D'Aleo-Sotas University of Calgary
  • Christine Phan University of Calgary
  • James Johnston University of Calgary
  • David Nguyen University of Calgary
  • Nick Jette University of Calgary
  • Dan Ziemianowicz University of Calgary
  • Mayi Arcellana-Panlilio University of Calgary

Keywords:

Biotherapeutics, cell-based therapeutics, regulations, Health Canada, Public Health

Abstract

The advancing industry of biotherapeutics is providing the public with new promising and innovative drugs which may pose risks if their production, distribution, and marketing are not directly governed by legislation. Apart from international agreements, such as the Cartagena Protocol, there are no specific and direct laws or regulations governing manipulated cell-based therapeutics in Canada. The introduction of these laws and regulations in Canada will allow for the safe research and use of biotherapeutics in a proactive manner.

Author Biographies

Shalpinder Dhothar, University of Calgary

Faculty of Science, Student

Elena Fekete, University of Calgary

Faculty of Science, Student

Nishi Patel, University of Calgary

Faculty of Science, Student

Tiffany Dang, University of Calgary

Faculty of Engineering, Student

Rachelle Varga, University of Calgary

Faculty of Science, Student

Syed Jafri, University of Calgary

Cumming School of Medicine, Student

Neliza Mendoza, University of Calgary

Faculty of Engineering, Student

Siddhartha Goutam, University of Calgary

Cumming School of Medicine, Student

Nilesh Sharma, University of Calgary

Faculty of Science, Student

Noshin Karim, University of Calgary

Faculty of Engineering, Student

Nicholas D'Aleo-Sotas, University of Calgary

Faculty of Science. Student

Christine Phan, University of Calgary

Faculty of Science, Student

James Johnston, University of Calgary

Cumming School of Medicine, Student

David Nguyen, University of Calgary

Faculty of Engineering, Student

Nick Jette, University of Calgary

Cumming School of Medicine, MD/PhD Candidate

Dan Ziemianowicz, University of Calgary

Cumming School of Medicine, Graduate Student

Mayi Arcellana-Panlilio, University of Calgary

Cumming School of Medicine, Professor

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Published

2017-07-24

Issue

Vol. 6: (2016-2017)

Section

Review Articles

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