Health Canada has been working to better understand the evolving health product landscape and identify what regulatory changes might be needed. As part of this review, the department is seeking feedback from professionals regarding the development of clinical trial regulations and pathways for advanced therapeutic products (ATPs). The following questions are provided to guide your input:
1. What products would you want to put forward for consideration under the ATP pathway?
2. Can you suggest any good models of an enhanced client “concierge” service that would help companies wishing to be considered for the ATP pathway?
3. What recommendations do you have for creating clinical trials regulations that would attract clinical trials in Canada and be an effective model in the Canadian context?
For more information on how to participate, please visit: https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/enabling-advanced-therepeutic-products-modernizing-regulation-clinical-trials.html
For more background information, please see the full discussion paper.