Unmodified Human-derived Mesenchymal Stromal Cells Added

Summary#

This is Order 2020-112-13-01 Amending the Domestic Substances List. It adds Unmodified human-derived mesenchymal stromal cells to Part 5 of the Domestic Substances List, and the order came into force on August 21, 2020.

What it does#

• Adds Unmodified human-derived mesenchymal stromal cells to Part 5 of the Domestic Substances List.
• Because the cells are now on the list, they are no longer subject to the notification and assessment steps that apply to living organisms not already on the list under the New Substances Notification Regulations (Organisms).
• The change is administrative: it follows the departments’ assessment that the organism had already been manufactured or imported by the notifier and that the statutory assessment period had ended without conditions being imposed.

Who's affected#

• Companies and labs that make, import, sell or use Unmodified human-derived mesenchymal stromal cells in Canada — for example, biotech firms, clinical‑research groups and some hospitals.
• Regulators at Health Canada and Environment and Climate Change Canada as it changes what notifications they will receive for this item.
• The broader public is unlikely to notice direct effects; the change mainly affects people who handle or trade these specific cells.

Why it matters#

• For businesses and researchers, this removes one regulatory step for these specific cells, which can make it quicker or simpler to bring them into use in Canada.
• It does not mean the government is endorsing the safety or effectiveness of the cells. Other laws, rules, or approvals (for example for clinical use) may still apply.
• The government’s analysis said the order has no expected costs or impacts on small businesses and is administrative in nature.