On January 7, 2019, Health Canada opened a consultation on whether to include the names of sponsor companies on the generic submissions under review list (GSUR) for Abbreviated New Drug Submissions (ANDSs). This type of information was recently added to the list of drug and health product submissions under review (SUR) that Health Canada has maintained since 2015.
Historically, the SUR list has been restricted to New Drug Submissions (NDSs) and Supplemental New Drugs Submissions (SNDSs). With respect to each of these submissions, the SUR list includes the medicinal ingredient, therapeutic area, and month in which the submission was accepted, as well as the recent addition of sponsor and “submission class” information for submissions accepted on or after October 1, 2018. The GSUR was launched in October 2018 with a more limited set of data restricted to the medicinal ingredient, the therapeutic area, and the number of submissions under review, but not the month the submission was accepted or the name of the company sponsor.
The consultation on adding sponsor names to the GSUR list is open until February 8, 2019. In seeking feedback, Health Canada has asked for (i) a description of the person providing feedback (e.g., General Public, Health Professional, Pharmaceutical Industry), (ii) the potential impact of including the name of the sponsor, and (iii) if and how this information would be useful to the person providing feedback.
For details on the consultation see: https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/notice-company-names-generic-submissions-under-review.html
