Health Canada had advised that beginning on October 1, 2018, it would implement certain proposals for its prescription drug product transparency initiatives. Health Canada will start providing Regulatory Decisions Summaries (RDSs) for approvals of certain drugs approved on the basis of abbreviated new drug submissions (ANDSs). For submissions accepted into review on or after October 1, 2018, Health Canada now provides the following information:
- The Submissions Under Review List now includes sponsor names and submission class for new drug submissions and supplemental new drug submissions; and
- The new, separate Generic Submissions Under Review (GSUR) List includes a list of the generic submissions under review by medicinal ingredient.