AAV Viral Vectors Added to Domestic Substances List

Summary#

This is Order 2025-112-09-01 Amending the Domestic Substances List, a short federal order that adds two specific viral‑vector organisms to the Domestic Substances List. Because they are now on the list, those two organisms are no longer treated as “new” under the federal chemicals/organisms notification rules as of their registration on September 8, 2025.

What it does#

• Adds these two living organisms to the Domestic Substances List:
  • Recombinant and non-replicative adeno‑associated virus serotype rh74 containing a shortened human dystrophin gene (SRP‑9001).
  • 19790-8 — Recombinant and non-replicative adeno‑associated virus 2/8 producing a modified protein phosphatase inhibitor 1.
• Because they are listed, those organisms are no longer subject to the notification and assessment requirements of the New Substances Notification Regulations (Organisms) for being “new to Canada.”
• The order was registered and came into force on September 8, 2025. The order does not approve, endorse, or exempt these organisms from any other laws or rules.

Who's affected#

• Companies that make, import or supply these specific viral vectors — for example, firms developing gene therapies or supplying research materials.
• Research institutions and clinical groups that use or plan to use these specific vectors.
• Federal regulators, because the administrative status of these organisms in the national inventory has changed.
• The general public and patients could be indirectly affected through changes in availability of research or therapies that use these vectors, but the order itself is an administrative change and does not change clinical approvals or safety rules.

If it’s unclear who exactly will manufacture or import them in Canada, the source does not specify the companies involved.

Why it matters#

• Being added to the Domestic Substances List removes a regulatory hurdle: businesses no longer have to file “new substance” notifications for these two organisms, which can make it easier to bring them into Canada for research or commercial use.
• This can speed up supply and development steps for gene‑therapy research or production, but it does not mean the government has judged them safe for therapeutic use — other safety, clinical and transport rules still apply.
• For the public, the change is mainly administrative. It affects how the federal government tracks and manages new biological materials, and it may influence how quickly certain research or products move through early stages in Canada.