AAV5 FIX-Padua Vector Added to Domestic List

Summary#

Order 2025-112-03-01 Amending the Domestic Substances List adds one specific gene‑therapy related virus vector to Canada’s inventory of existing substances. The change took effect when the order was registered on February 28, 2025 (published March 12, 2025). As a result, that organism is no longer treated as a “new” organism for notification and assessment under the government’s new‑substances rules.

What it does#

• Adds this living organism to Part 5 of the Domestic Substances List:
  • Recombinant and non-replicating adeno-associated virus serotype 5 (AAV5) vector containing the codon-optimized coding DNA sequence for the human coagulation factor IX variant R338L (FIX-Padua).
• Removes the requirement for that organism to go through the pre-market notification and assessment steps in the New Substances Notification Regulations (Organisms), because the government found it had already been manufactured in or imported into Canada by the notifier and the assessment period ended.
• The order is made under the Canadian Environmental Protection Act, 1999 and came into force on registration (February 28, 2025).
• The order does not by itself approve, endorse or exempt the organism from any other Canadian laws or regulations that might apply.

Who's affected#

• Companies and organizations that make, import, sell or handle this specific AAV5 vector — for example, biotech firms, contract manufacturers, suppliers and research labs.
• Clinical trial sponsors and health‑care organizations that plan to use or supply this exact vector in Canada.
• Regulators and policymakers who oversee biotechnology and controlled substances in research and health care.

It is not clear from the notice which specific businesses or institutions are involved. The addition simply reflects that someone already manufactured or imported this organism and completed the required notifications.

Why it matters#

• Being on the Domestic Substances List means the organism no longer needs the extra pre-market notifications under the New Substances rules. That can make it quicker and simpler for the parties already working with it to keep importing, manufacturing or using it in Canada.
• For the public, the change signals that regulators have already reviewed the paperwork required for a new organism and chose to add it to the inventory. It is not a safety approval or an endorsement of the product.
• Other federal, provincial or health rules (including those that govern clinical trials, drug approvals, transport or biosafety) may still apply.