Consultation: Draft guidance on advanced therapeutic products framework

From: Health Canada

Current status: Open

Opened on December 28, 2022 and will close to new input on March 13, 2023.

Health Canada is seeking feedback on a draft guidance document on advanced therapeutic products framework.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

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.

Join in: How to participate

Send us an email

Send an email to with your ideas or comments to make yourself heard.

Participate by mail

Send a letter with your ideas and input to the address in contact information below.

Who is the focus of this consultation

This consultation is intended for stakeholders interested in:

Key questions for discussion

We are seeking feedback to ensure that this high-level guidance is as clear as possible.

Related information

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

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