Health Canada’s Scanning and Consultations on What’s Next for Health Product Regulation



Health Canada’s Scanning and Consultations on What’s Next for Health Product Regulation


Posted: Monday May 6th, 2019

By: Pinky Mazumder

With the rapid evolution of healthcare technologies, Health Canada undertook a scanning exercise to identify key drivers involved in shaping the future of healthcare.  The scan included a review of scientific research and publications, media, and collaborating with international regulators to identify key drivers in the evolution of health care and key technologies to be considered.  The following are some of the key technologies identified by Health Canada to be investigated in the evolution of health products:

-Artificial intelligence
-Advanced cell therapies
-Big data to inform patient decisions
-3D printing of health products
-New ways to deliver drugs (e.g. nano-carriers, implantable devices)
-Gene editing

This project led to agency consulting with leaders across the country to discuss emerging technologies and the challenges faced during the innovation process.  Stakeholders highlighted that the existing framework poses a challenge for the way new and innovative health products are designed, manufactured, and used.  For instance, some emerging technologies are difficult to classify with the current classification framework making it difficult to understand the requirements for such technologies.  In addition, stakeholders also noted that although the Canadian system has a high calibre framework for clinical trial authorizations, the framework needs to adapt to the evolution of new technologies in order to support research in Canada.   

In addition, stakeholders also noted the need for oversight of new technologies in the absence of large-scale studies to demonstrate safety and efficacy.  Stakeholders suggested a flexible and risk-based approach to market authorization that allows early or conditional authorization with ongoing product research and surveillance.  Overall, the discussion with stakeholders across the nation provided Health Canada with valuable insight into several areas of development and new technologies at critical stages of development.  For more information on the information gathered from the consultations, please refer to the Health Canada publication provided in the references below. 

Thank you for reading Regulated Affairs, the CAPRA blog.  CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs.   Please feel free to share our blog posts and join us on social media.

Reference:

What we heard: A summary of scanning and consultations on what’s next for health product regulation

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/consultation-summary-health-product-regulation.html