List of generic submissions under review now available

As previously reported, Health Canada advised that beginning on 1 October 2018, it would implement certain proposals for its prescription drug product transparency initiatives (for further details please see "Health Canada to implement further pre-market transparency initiatives for prescription drugs"). In particular, Health Canada will start providing regulatory decision summaries for the approval of certain drugs approved on the basis of abbreviated new drug submissions. For submissions accepted into review on or after 1 October 2018, Health Canada now provides the following information:

• The Submissions Under Review List now includes sponsor names and submission classes for new drug submissions and supplemental new drug submissions.
• The new, separate Generic Submissions Under Review List includes a list of the generic submissions under review by medicinal ingredient.

For further information on this topic please contact Urszula Wojtyra at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (uawojtyra@smart-biggar.ca). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.