Canada: New Approach to Compendial Reviews

Canada's Natural Health Products Directorate (NHPD) has announced that it has adopted a new approach to the review of compendial Product Licence Applications. As of last month, the Directorate is no longer issuing Information Request Notices (IRNs) for deficient compendial Product Licence Applications. Rather, it is expecting Product Licence Applications and proposed label text to correspond in full to that which is outlined in the monograph or it will refuse the application.

More information is available at: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/bulletins/approach-procedure-eng.php