Health Canada and the Public Health Agency of Canada Release Report on Cutting Red Tape

In response to stakeholder concerns about outdated and overly prescriptive administrative processes, the Government of Canada launched a review of administrative burdens (referred to as “red tape”) across all federal departments and agencies this summer. On September 8, 2025, Health Canada and the Public Health Agency of Canada (PHAC) jointly published a Report on Red Tape Reduction (Report), which summarizes the results of their review.

This Report presents the initiatives and actions that Health Canada and PHAC have identified to reduce regulatory red tape in the health products and consumer goods sectors, without undermining the core purpose of regulations to protect health and safety. The initiatives are organized into five themes:

1. International alignment and reduction of trade barriers
2. Improving client experience and service delivery
3. Risk-based regulating
4. Streamlining regulations, simplifying rules and enhancing flexibility
5. Enabling new products and technologies

The Report highlights a total of 42 initiatives, including 12 initiatives that are completed or near completion and 30 that should be completed over the coming years. Many of the initiatives had been previously announced but now have clearer next steps, opportunities for industry participation and timelines.

Examples of proposed initiatives include:

• Short Term – Changes to MDEL Requirements. The Report states that in fall 2025, Health Canada intends to publish proposed changes to the Medical Devices Regulations to clarify Health Canada’s Medical Device Establishment Licence (MDEL) requirements. This includes changes to no longer require Canadian MDEL holders to import medical devices from foreign distributors who also have an MDEL. This would eliminate unnecessary regulatory duplication and better align with international practices. Industry had advocated for this change, alleging that foreign medical device companies were disincentivized from launching products in Canada based on the requirement to hold an MDEL. This change is expected to positively affect the supply of medical devices in Canada.
• Medium Term – Modernized Clinical Trial Framework. The Report acknowledges that the current “one-size-fits-all” regulatory framework for clinical trials creates unnecessary burdens for the research community in Canada. In response, Health Canada is developing a new framework for clinical trial requirements for drugs, whereby regulatory requirements are determined based on the risks associated with the drug at issue. This change is expected to encourage clinical trials to be conducted in Canada and to improve access to novel therapies. The Report provides that Health Canada intends to publish a regulatory proposal for consultation in 2026.
• Long Term – Simpler Requirements for Natural Health Products (NHPs) and Non-Prescription Drugs (NPDs). The Report recognizes that the regulatory requirements for NHPs and NPDs are outdated and inflexible under the current regulations. Particularly, while NHPs and NPDs are lower-risk products compared to prescription drugs, their regulatory requirements are largely similar, particularly for NPDs. Health Canada reports that within three years, it intends to publish a regulatory proposal to simplify the registration process and develop a more flexible risk-monitoring process for many of these products. This issue has been on Health Canada’s radar for many years already, and it remains to be seen how quickly it will progress.

At a time when various industries in Canada are facing unexpected and rapidly evolving burdens due to tariffs and increased regulation, Health Canada’s efforts to eliminate unnecessary hurdles for various healthcare businesses operating in Canada are likely to be a welcomed change.

For more information, please contact the authors or any other member of our Health & Product Regulatory or Life Sciences groups.