Two Gene Therapy Organisms Added to Domestic List

Summary#

Order 2025-112-06-01 Amending the Domestic Substances List (SOR/2025-171) adds two living organisms to Canada’s inventory of existing substances. The order came into force on August 29, 2025 after decisions by the Minister of the Environment and the Minister of Health.

What it does#

• Adds two named organisms to Part 5 of the Domestic Substances List:
  • Recombinant and non-replicative adeno-associated virus serotype SLB101 expressing a genetically modified human microdystrophin gene (SGT-003)
  • Recombinant human T-cells expressing an anti-CD19/anti-CD20 chimeric antigen receptor transgene (JNJ-90014496)
• Because these organisms are now on the Domestic Substances List, they are no longer subject to the notification and assessment rules in the New Substances Notification Regulations (Organisms).
• The ministers concluded that the required notification and assessment steps had already been completed for these organisms and that there were no outstanding conditions blocking their addition.

Who's affected#

• Companies or people who manufacture or import those specific organisms into Canada.
• Biotechnology and biomedical developers, including those working on gene therapies and cell therapies.
• Research labs or clinical trial sponsors that plan to work with these exact organisms.
• Regulators and safety officers who track which substances must undergo pre-market notification.

If it is unclear whether a specific product or strain is the same as the named organisms, affected parties should check with Environment Canada; the order lists the exact names used to identify them.

Why it matters#

• Being added to the Domestic Substances List means these two organisms no longer need the separate pre-market notification process under the New Substances Notification Regulations for organisms. That can make it administratively easier to import or manufacture them in Canada.
• The addition is administrative, not a safety approval. The government says the orders do not amount to an endorsement, and other laws and oversight (for example, health, clinical trial, or biosafety rules) may still apply.
• This matters in practice for companies and researchers involved in advanced gene and cell therapies, because it affects how quickly and easily they can bring these specific materials into use in Canada.