Guidance for Submitting Whole Genome Sequencing (WGS) Data to Support the Pre-Market Assessment of Novel Foods, Novel Feeds and Plants with Novel Traits

Issue Date: March 2018

Summary

The purpose of this document is to provide guidance to industry on the use of whole genome sequencing (WGS) to generate data for pre-market submissions for genetically modified plants. Commercial platforms for high-throughput sequencing were launched in the mid-2000s and continue to undergo rapid development. These platforms are now increasingly affordable, and with over a decade of experience, they are also more reliable and accessible to developers with different levels of resources. Adoption of WGS has been widespread in biological, medical and agricultural research, and more recently in clinical diagnostics and epidemiology. Canadian regulatory agencies and our international counterparts have and continue to receive pre-market submission packages that include WGS data. Given the complexity of WGS data, industry has requested guidance that will enable them to compile pre-market submission packages that facilitate the regulatory review process. The use of WGS technology is optional and data generated using traditional molecular biology methods are still acceptable.

Guidance Document

To obtain an electronic copy of the document, Guidance for Submitting Whole Genome Sequencing (WGS) Data to Support the Pre-Market Assessment of Novel Foods, Novel Feeds, and Plants with Novel Traits, please send an e-mail to hc.publications-publications.sc@canada.ca with the subject heading "HC CFIA Guidance Whole Genome Sequencing".

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