Consultation: Draft guidance on advanced therapeutic products framework: Closed consultation
From: Health Canada
Current status: Closed
This consultation ran from December 28, 2022 to March 13, 2023.
Health Canada was seeking feedback on a draft guidance document on advanced therapeutic products framework. Advanced therapeutic products (ATPs) are drugs, medical devices or any combination of drugs and medical devices that are so unique, complex and distinct that they fundamentally challenge:
- existing regulations
- Health Canada's ability to protect people's health
The outcome will be a final guidance document that provides an overview of how Health Canada designates and regulates ATPs under sections 21.9 to 21.96 of the Food and Drugs Act.
Who was the focus of this consultation
This consultation was intended for stakeholders interested in:
- using an already established tailored ATP pathway
- developing a therapeutic product that could be designated as an ATP
Key questions for discussion
We were seeking feedback to ensure that this high-level guidance is as clear as possible.
- Sections 21.9 to 21.96 of the Food and Drugs Act
- Regulating advanced therapeutic products
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Building 6, Address Locator: 0601B
100 Eglantine Driveway
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