On April 30, 2010, Health Canada released a finalized guidance document relating to non-clinical laboratory study data reporting drug product applications and submissions: adherence to good laboratory practice. The documents stated to apply to all sponsors to submit non-clinical study data from a clinical trial application and other various applications and non-clinical studies include all in vitro and in vivo testing not involving human subjects performed to determine the safety of human drugs. It is noted that the final guidance documents addresses comments received as a result of the August 27, 2009 to October 26, 2009 consultations on the draft guidance. The document is effective April 30, 2010.

For more information, please see the following link:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/glp_bpl-eng.php