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.
Related Publications & Articles
-
Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision
On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data...Read More -
CIPO will not issue patents on July 9 or July 16
The Canadian Intellectual Property Office (CIPO) will be launching a new online portal for patent services, MyCIPO Patents, on July 15, 2024.Read More -
2024 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories ...Read More