Health Canada issues new guidance for GLP studies

Health Canada has released a new draft guidance document for all companies submitting non–clinical data in Clinical Trial Applications, New Drug Submissions or Drug Identification Number applications, appointing the Standards Council of Canada (SCC) as the monitoring authority for good
laboratory practice (GLP) compliance of test facilities within Canada.

Health Canada expects that all studies submitted in support of pharmaceutical, radiopharmaceutical or biologic drugs will be compliant with GLP, as outlined within the guidance document (click here to review the document on Health Canada’s website).

Facilities that submit data to Health Canada will need to ensure they obtain OECD GLP recognition from the SCC in order to comply with this Health Canada requirement.

As the only laboratory in Canada with OECD GLP recognition by the SCC in four fields (pharmaceutical, industrial chemistry, pesticides and
veterinary drugs), CANTEST has been conducting GLP studies for Canadian and international clients for many years (click here to view CANTEST’s scope of recognition).

If you have any questions about the impact of Health Canada’s new guidance on your studies, please email us or visit www.cantest.com.

For more information on the OECD GLP recognition process, please visit the SCC website.