Policy Review: Addressing the Complex Challenges of Regulating Biotherapeutics

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


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.


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

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