Notice: Expanding the list of generic drug submissions under review

2024-02-23 16:30:00

February 23, 2024 Our file number: 23-109491-316

The Generic Drug Submissions Under Review (GDSU) List helps make Health Canada’s review processes more transparent. The list provides Canadians with information about generic versions of brand-name prescription drugs currently under review in Canada. The ADP list includes Abbreviated New Drug Submissions (ANPs) accepted for review as of October 1, 2018.

The PMGCE list currently contains the following information:

Medicinal ingredient(s) Therapeutic area Number of submissions under review with Health Canada that month

Health Canada will expand the information in the PMGCE to include the following:

Year and month in which the submission was accepted for review, for each PADN. Name of company (sponsor) (for PADNs accepted for review on or after April 1, 2024 only)

To account for this expansion, the column displaying the number of submissions under review will be removed, and the PADNs under review will be divided into individual rows in the expanded list of PMGCEs.

Context

Comments received through various consultations since 2016 have highlighted the need to increase the transparency of generic medicine presentations and to apply transparency measures equally between innovative and generic medicine presentations. Launched in 2018, the PMGCE list is part of the transparency measures implemented in response to stakeholder feedback. The PMGCE list was announced as part of Phase III of the Drug Submissions Under Review (PCE) initiative, which publishes information on new prescription drug submissions and their supplements in exam course.

A consultation took place in 2019 to assess the use and impact for stakeholders of adding the name of the company (promoter) to the list of PMGCEs. Results were mixed on the need for this information to be disseminated and whether its dissemination could cause harm to drug sponsors.

However, since then, requests for information under the Access to Information Act (ATIA) for information associated with PADNs on the PMGCE list have increased significantly, with few third-party objections to regarding the disclosure of this information have been received. Expanding the list of PMGCEs will facilitate proactive access to information and reduce the need for access to information requests. Additionally, it is likely to improve the consistency of transparency measures across branded medicines, biosimilar medicines and generic prescription medicines.