Submissions Relying on Third-Party Data (SRTD) – Health Canada Background
In 2015 Health Canada introduced the Submissions Relying on Third-Party Data (SRTD), a new regulatory pathway to submit New Drug Submissions (NDSs) or Supplements to NDSs (SNDSs) for market approval of pharmaceuticals, biologics, and radiopharmaceuticals. The primary draw of an SRTD is that it substantially relies on literature and market experience and does not rely on the sponsor conducting clinical and nonclinical studies. While there is a reliance on the literature providing safety and efficacy data, the same standards for approval as a conventional NDS or SNDS submission still apply (i.e., substantial evidence of safety and efficacy).
Health Canada recommends the sponsor submit an SRTD when the following nine conditions and requirements are adequately addressed:
- Provide a rationale to explain why a conventional drug submission is not being filed.
- Provide a complete chemistry and manufacturing data package (Module 3) for the proposed drug product.
- Provide evidence, based on comparative pharmaceutical and/or comparative bioavailability data, to establish that the product used in the literature is representative of the proposed commercial product.
- Provide evidence that the product has extensive foreign market experience with the same medicinal ingredient (minimum 10 years), or that the same medicinal ingredient is currently or has previously been marketed in Canada (under same conditions of use).
- Provide a systematic review of the literature using the Cochrane Handbook for Systematic Reviews of Interventions and presented in the form as outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.
- Provide copies of all referenced documents.
- Provide complete and current evidence-based information for the development of a Canadian Product Monograph.
- Provide a Canadian Risk Management Plan.
- Attend a pre-submission meeting with Health Canada to discuss the safety and efficacy evidence required to support market authorization and the data requirements to bridge the proposed product to the reference product.
Bridging to the literature
The primary obstacle for successful SRTD submissions is bridging the proposed product to the reference product in the literature. If a bridge to the reference product cannot be established, then the data can only be considered supportive and not pivotal. This is important as pivotal clinical studies are required to provide efficacy and safety data for the proposed product. To successfully bridge to the reference product, the sponsor must demonstrate that the reference product is representative of the proposed commercial formulation and that they will have the same in vivo performance. For bridging to aqueous solutions, comparative physicochemical data between the reference product and proposed product is generally sufficient; however, for other products (i.e., solid oral dosage forms) a demonstration of comparative bioavailability is required. This involves using the same dose, in comparable dosage form, and using the same route of administration.
Bridging to the reference product may be difficult to accomplish as the literature may lack details on the tested product (e.g., only common drug substance name and not the brand name or formulation details), report using a discontinued product, report multiple iterations of a single product (after formulation changes), or even report multiple products that contain the same medicinal ingredient.
Submitting through the SRTD pathway does not allow eligibility for market exclusivity, even if the medicinal ingredient has never been previously approved. This is due to Health Canada requiring investment of time and effort in exchange for market exclusivity and use of third-party data is not considered sufficient. Additionally, the SRTD pathway cannot circumvent data protection regulations for a reference product marketed in Canada if it is on the Register of Innovative Drugs.
Ultimately, the SRTD pathway provides a quicker and less expensive option to acquire Canadian market approval for foreign-marketed pharmaceuticals, biologics, and radiopharmaceuticals.
Where can I get additional information?
For more information, please contact us at moc.k1603613174isnir1603613174tni@o1603613174fni1603613174 or call us directly at 905-364-7800.
Evan Borman, PhD.
905-364-7800 ext. 201
Health Canada. Health Products and Food Branch, Drug Submissions Relying on Third-Party Data (Literature and Market Experience) [Internet]. Ottawa: Minister of Public Works and Government Services Canada; 2015. Available Online: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/srtd_pfdt_gd_ld-eng.pdf.
Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.0 (updated July 2019). Cochrane, 2019. Available Online: www.training.cochrane.org/handbook.
Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009 Jul;6(7)e1000097.