Consultation: Draft guidance on advanced therapeutic products framework: Closed consultation

From: Health Canada

Health Canada was seeking feedback on a draft guidance document on advanced therapeutic products framework.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.

Related information

• Sections 21.9 to 21.96 of the Food and Drugs Act
• Regulating advanced therapeutic products

Contact us

Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Building 6, Address Locator: 0601B
100 Eglantine Driveway
Tunney's Pasture
Ottawa, Ontario
K1A 0T6
Email: atp-ptn@hc-sc.gc.ca