Health Canada Draft Guidance Document: Drug Submissions Relying on Third-Party Data [Literature and Market Experience]

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/srtd_draft_guid_pfdt_ebauch_ld-eng.pdfHealth Canada has released a consultation document regarding drug submissions relying on third-party data (literature and market experience). The guidance applies to NDSs and SNDSs and “should only be submitted to Health Canada for compelling reasons and with appropriate justification.” Health Canada will decide to accept the submission on a case by case basis. The guidance provides information on the conditions and requirements of submissions relying on third-party data (SRTDs) to assist sponsors in the preparation and filing of their drug submission.

In the instance “where an NDS or SNDS substantially relies on literature and market experience to support clinical safety and efficacy, sponsors are required to provide evidence demonstrating the extent to which the data forming this part of the submission mirrors the proposed indication for use in terms of dosing, population, intervention and outcome measures.” On page 4 this guidance outlines 10 conditions that must be adequately addressed by the sponsor in order for a NDS or SNDS relying on SRTDs to be submitted.

Moreover, this guidance outlines that Foreign Review Reports, Post-Marketing Reports, and Drugs available through Special Access Programme (SAP) may be submitted as sources of evidence but individually do not provide sufficient support for the safety and efficacy of the product.

This guidance document is open for a 90-day comment period starting June 13, 2014 to September 13, 2014.

The gudiacne can be accessed here:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/srtd_draft_guid_pfdt_ebauch_ld-eng.pdf

Share Button