While the federal government has made red tape reduction a stated priority, recent updates show that meaningful burden reduction will depend on how reforms to licensing, labeling and system operations are ultimately implemented.
At a policy level, red tape reduction has been advanced through horizontal government-wide reviews, including Health Canada’s Red Tape Reduction Report. Within this, the Government of Canada has signaled sector-specific changes for NHPs, notably potential reforms to product licensing pathways and labeling requirements.
Regarding licensing, proposed shifts toward streamlined or notification-based approaches for lower-risk products are intended to reduce review timelines and administrative bottlenecks. These proposals acknowledge long-standing industry concerns with delays, backlog and duplicative review processes.
On labeling, the government has signaled openness to revisiting current requirements, which, as originally conceived, were complex and costly. This is a critical area: Previous regulatory changes introduced significant redesign and compliance costs, particularly for small and medium-sized enterprises (SMEs) managing large product portfolios.
While these signals are positive, early indications suggest that the proposed measures may deliver only modest relief if not designed as proper, meaningful modernization efforts. For example, streamlined licensing pathways that reduce front-end review time while retaining the same underlying evidence, labeling and post-market requirements, will have limited impact on overall compliance costs. Similarly, labeling updates that do not address formatting rigidity, update triggers and alignment with international approaches risk being perceived as additional red tape.
Industry is now watching closely to ensure that any discussions on red tape deliver real flexibility rather than incremental adjustments that layer on new elements without clear benefits.
More broadly, the sector continues to experience what many describe as “hidden red tape”, a burden that is driven not by regulation itself, but by how it is implemented by Health Canada. Companies report inconsistent interpretation of requirements, evolving and sometimes expanding evidence expectations, and a lack of predictability in the review process. Even when guidance documents and monographs exist, submissions are frequently subject to additional information requests, creating delays and increasing costs.
Recent updates to Good Manufacturing Practices (GMP), particularly through revised guidance (GUI-0158 v4), further illustrate this trend. While the regulatory framework has not fundamentally changed, expectations have shifted toward more formalized quality management systems, including enhanced requirements for risk management, corrective and preventive actions (CAPA), change control and internal audits. These changes have increased documentation and compliance burden, disproportionately affecting SMEs due to significant increases in costs in a short time period.
At the same time, competitiveness pressures are intensifying. A key concern is the uneven enforcement landscape, particularly in cross-border e-commerce. Canada’s “90-day personal importation” provision is increasingly used at a commercial scale, allowing foreign products to enter the market without meeting the same regulatory requirements as domestic products. This creates an uneven playing field, undermines compliant Canadian businesses and raises broader questions about regulatory sovereignty and consumer protection.
Taken together, these dynamics highlight the need for a more targeted and outcomes-focused approach to red tape reduction. Industry is calling for:
- Licensing reforms that deliver meaningful reductions in both time and cost, not just review timelines;
- A true modernization of labeling that prioritizes flexibility;
- Greater consistency and transparency in evidence requirements and regulatory decision-making;
- Operational improvements within Health Canada, including more predictable review processes and clearer communication;
- Modernized enforcement approaches that address cross-border disparities and restore competitive balance.
Canada has an opportunity to reestablish itself as a global leader in the NHP sector. Doing so will require moving beyond high-level commitments and ensuring that current reform initiatives translate into measurable, on-the-ground reductions in industry’s burden.
