In this webinar...
Health Canada's policy of Submissions Relying on Third-Party Data (SRTD) provides sponsors with a pathway to market authorization for globally marketed products with extensive post-market safety data. Under the SRTD guidance, sponsors can leverage published literature & foreign reviews generated in support of marketed brand-name products, to support the safety and effectiveness of the proposed drug under the recommended purpose and conditions of use. This pathway provides Generic drug manufacturers the opportunity to bring new drugs, new formulations and new indications to the under-served Canadian market.
There are several challenges associated with filling a submission relying on 3rd party data; the most pertinent of which is the availability of quality peer-reviewed published data, including foreign reviews for the specific medicinal ingredient under the proposed indication(s) and conditions of use. The granularity required to properly assess and summarize the safety and effectiveness of the proposed product under ICH CTD requirements is most-often lacking; specifically, with regards to details on the product development rationale, justifications supporting non-clinical and clinical protocols, the selection of key outcome measures, and much needed raw pharmacokinetic data. The absence of such detail can significantly affect ability to adequately respond to Health Canada questions raised during submission.
This presentation will provide an overview of the challenges faced, risk mitigation strategies and the keys to a successful filing of a Submission Relying on Third-party data.
At the conclusion of the webinar, participants should be able to:
- Develop an understanding of the primary SRTD requirements, key challenges, and important risk factors
- Integrate published literature to ICH Module 2 Overviews and Summaries
- Develop the bridging strategies to establish the link to the drug product used in the supporting literature
- Andrea Bailey, PhD, Regulatory Affairs Scientist, Pharmascience Inc.