Navigating Submissions Relying on Third-Party Data (SRTD) in Canada: A Strategic Guide for Pharmaceutical Companies
Expert regulatory guidance from Intrinsik Corp.
Streamlining your path to Canadian market approval
What is an SRTD?
Since 2015, Health Canada’s Submission Relying on Third-Party Data (SRTD) pathway offers pharmaceutical companies a potentially cost-effective alternative to traditional New Drug Submissions (NDS). Instead of conducting extensive original clinical trials, SRTDs leverage published literature and market experience to demonstrate safety and efficacy.
Although the SRTD pathway has parallels with the 505(b)(2) pathway in the United States and the hybrid/well-established use pathway in the European Union, it represents a discrete regulatory framework with its own distinct set of requirements and considerations.
Key Benefits:
- Reduced development costs and timelines
- Relies on existing clinical and nonclinical data
- Faster route to Canadian market access
Important Limitations:
- SRTDs are not eligible for market exclusivity, even for new active substances in Canada
- Does not apply to natural health products, veterinary NDS, extraordinary use NDS, or certain biologics such as vaccines
The Challenge
While SRTDs offer potential cost and time savings, they do not offer a shortcut on rigor. These submissions must meet the same safety and efficacy standards as a conventional NDS. This demands a sophisticated regulatory strategy and literature review process. As seasoned regulatory and medical writing consultants in Canadian drug submissions, Intrinsik has seen firsthand both the exciting opportunities and the common pitfalls companies face with SRTDs.
Success depends on addressing these nine essential elements:
- Clear SRTD Rationale – Provide justification supporting SRTD filing and why a conventional submission is not being submitted
- Complete CMC Package – Submit a complete chemistry and manufacturing data package
- Product Bridging Evidence – Demonstrate that the reference product(s) in the literature studies is representative of your proposed product through comparative pharmaceutical and/or bioavailability data
- Market Experience – Demonstrate extensive foreign market experience with the same medicinal ingredient (minimum 10 years under the same conditions of use), OR evidence of current or previous Canadian marketing for the same medicinal ingredient under the same conditions of use
- Systematic Literature Review – Conduct a systematic literature review following Cochrane/PRISMA standard methodology
- Complete Documentation – Provide copies of all referenced studies and reports
- Product Monograph – Provide complete and current evidence-based information for Canadian labeling
- Risk Management Plan – Submit a comprehensive Canadian RMP
- Pre-Submission Meeting – Attend a pre-submission meeting with Health Canada to discuss evidence and bridging requirements
Health Canada emphasizes that SRTD submissions must prioritize high-quality, relevant evidence over sheer volume. This means your submission requires:
- Methodological transparency, with clear documentation of literature search strategy and study selection criteria
- Critical appraisal with rigorous evaluation of study quality, relevance, and bias
- Application of appropriate statistical and scientific evaluation methods
The Make-or-Break Factor: Literature Bridging – A Common Source of SRTD Difficulties
One of the most significant hurdles for many SRTD submissions is demonstrating that your commercial product is comparable to the reference products cited in the selected literature and will have comparable in vivo performance. Without this crucial link – this “bridge” – your carefully compiled literature might not be considered substantial evidence of safety and efficacy. A successful SRTD submission hinges on establishing a clear and scientifically sound bridge.
Common Bridging Obstacles:
- Incomplete product details in published studies
- Discontinued reference products
- Multiple formulation versions across studies
- Generic drug names without specific brand information
Navigating these bridging complexities is where expert guidance becomes invaluable. If you’re unsure how to establish a strong connection between your product and the existing literature, contact us for a preliminary assessment at .
When SRTD Makes Strategic Sense – Ideal Candidates:
✓ Robust published literature with safety and efficacy supporting your indication
✓ Well-characterized reference products with detailed formulation information
✓ Established international market presence
✓ Aligned with Canadian intellectual property and data protection provisions
How Intrinsik Ensures SRTD Success
Why Experience Matters
Our regulatory affairs, medical writing, and nonclinical teams have successfully guided numerous SRTD submissions. We understand Health Canada’s expectations and help you avoid the common pitfalls that cause delays or rejections.
Our Track Record:
- Decades of Canadian regulatory experience with deep SRTD pathway expertise
- Proven success with SRTDs achieving for varied product types and indications
- Strong, established relationships with Health Canada, facilitating smooth communication
The Intrinsik Advantage: Partner with SRTD Experts
The SRTD pathway offers significant opportunities for efficient Canadian market access, but success requires specialized knowledge of Health Canada’s expectations, sophisticated literature reviews, and expert regulatory navigation.
At Intrinsik, we combine regulatory expertise and scientific knowledge with practical SRTD experience to maximize your chances of approval while minimizing timelines and costs.
Ready to explore the SRTD pathway for your product?
Please reach out to us at info@intrinsik.com.