Three Viral Vectors Added to Domestic List

Summary#

Order 2023-112-09-01 Amending the Domestic Substances List (SOR/2023-201) adds three living organisms to Canada’s inventory of domestic substances. The change took effect on registration (September 27, 2023) and removes these specific organisms from the new-substance notification rules that apply to organisms under the Canadian Environmental Protection Act, 1999.

What it does#

• Adds these living organisms to the Domestic Substances List:
  • Recombinant and non-replicative adeno-associated virus serotype 8 (rAAV8) expressing a humanized anti-vascular endothelial growth factor (VEGF) antibody fragment (RGX-314)
  • Recombinant human Herpes Simplex Virus encoding human Granulocyte Macrophage Colony-Stimulating Factor and the Gibbon Ape Leukaemia Virus surface GlycoProtein with R-sequence deleted
  • 19669-7 — Adeno-associated viral vector serotype 9 containing the human MECP2 gene
• Because these organisms are now on the List, they are no longer subject to the notification and assessment steps in the New Substances Notification Regulations (Organisms) that apply to organisms new to Canada.
• The order is administrative: it does not impose new rules, costs, or approvals for the substances, and it does not represent safety approval or a government endorsement.

Who's affected#

• Biotechnology and biopharmaceutical companies that make, import, or use these specific viral vectors.
• Research laboratories and clinical trial sponsors working with these vectors or related gene-therapy products.
• Importers and distributors of biological research materials.
• Regulators and compliance officers who track whether a substance must be reported under new-substance rules.

It is not always clear from the order which specific firms or projects will be affected; the immediate practical effect applies to anyone handling these exact organisms in Canada.

Why it matters#

• Removing these organisms from the new-substance notification rules makes it administratively easier for businesses and researchers to obtain and use them in Canada. The government says this should “facilitate access.”
• That can speed research, product development, or clinical work that uses these specific viral vectors.
• This change does not mean the government has declared them safe or approved them for medical use. Other laws, approvals, or safety rules (for example, health or biosafety regulations) can still apply.