CTX130 CAR-T and Ad26.COV2.S Added

Summary#

Order 2021-112-06-01 Amending the Domestic Substances List (SOR/2021-98) adds 2 living organisms to the Domestic Substances List. The order was registered and came into force on May 7, 2021. One entry is a CAR‑T cell therapy listed as CTX130 and the other is an adenovirus vector listed as Ad26.COV2.S.

What it does#

• Adds the following two items to Part 5 ("Organisms") of the Domestic Substances List:
  • Human allogeneic CAR T cells targeting CD70 ... (CTX130) — a genetically modified CAR‑T cell product (full technical name appears in the order).
  • Recombinant non-replicating human adenovirus type 26 encoding the severe acute respiratory syndrome coronavirus 2 Spike protein (Ad26.COV2.S) — an adenovirus vector carrying the SARS‑CoV‑2 spike protein.
• Because these organisms are now on the Domestic Substances List, they are no longer subject to the New Substances Notification Regulations (Organisms).
• The order was made under the Canadian Environmental Protection Act, 1999 and took effect on the day it was registered (May 7, 2021).
• Officials describe this change as administrative: it does not add new regulatory requirements or impose new costs.

Who's affected#

• Companies and organizations that manufacture, import or work with these specific living organisms — for example, biotech and pharmaceutical developers, and others who would have had to notify under the New Substances Notification Regulations.
• Regulatory and compliance teams that handle new‑substance filings and imports.
• The general public and most consumers are unlikely to notice a direct change from this administrative listing.

Why it matters#

• Practically, listing these organisms removes a specific paperwork/notification step under the New Substances rules for the businesses that already manufactured or imported them as described in the order. That can make it easier for those businesses to work with these products in Canada.
• This listing is not a safety approval, endorsement, or market authorization. Other laws and approvals (health, safety, clinical trial or product licensing rules) may still apply.
• The government says the change is routine and does not create extra costs or new regulatory burdens.