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Notice: Expansion of the Generic Submissions Under Review List February 23, 2024 Our file number: 23-109491-316 The Generic Submissions Under Review (GSUR) List helps make Health Canada's review processes more transparent. The list provides Canadians with information about…

Notice – Implementation of ICH E19: A selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials December 21, 2023 Revised: February 27, 2024 Our file number: 24-100744 – 309 Health Canada, as an official member to the…

Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28] February 28, 2024 Our file number: 24-101144 - 694 The purpose of this Notice of Amendment is to notify about the addition of elranatamab, epcoritamab, etranacogene dezaparvovec, fidanacogene elaparvovec,…

Memorandum of Understanding between the Competition Bureau and Health Canada Purpose Health Canada and the Competition Bureau (the " Bureau ") wish to acknowledge their important relationship and recognize that cooperation can contribute to improved delivery of Health Canada and…

Notice: Nomination call for members – Scientific Advisory Committee on Mental Health Disorders March 8, 2024 Our file number: 24-101558 - 539 Health Canada is seeking nominations for members for the Scientific Advisory Committee on Mental Health Disorders (SAC-MHD). The Committee…

Organization and document placement for Canadian module 1 April 2, 2024 Our file number: 24-102490-601 Health Canada has updated the organization and document placement for Canadian module 1 to reflect recent changes. This document contains a table outlining the Canadian module 1…

Notice: Multiple Additions to the Prescription Drug List (PDL) [2024-04-30] April 30, 2024 Our file number: 24-103562-165 The purpose of this Notice of Amendment is to notify about the addition of capivasertib, etrasimod and olipudase alfa to the Prescription Drug List (PDL) for…

Qualifying notice for Talvey (278277) - Canada.ca

Health CanadaCaptures 12Latest capture Apr 11, 2026en

Qualifying notice for Talvey (278277) Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: HC6-024-e270264 Control number: 278277 [employee name removed] [employee title removed] Janssen…

Common Electronic Submissions Gateway - Canada.ca

Health CanadaCaptures 12Latest capture Apr 11, 2026en

Common Electronic Submissions Gateway Subscribe to our RSS Feeds The Common Electronic Submissions Gateway allows you to provide secure regulatory transactions to Health Canada. On this page Background For more information and support Background Health Canada is working with our…

Innovative Medicines Canada (IMC): Final record of decisions May 12, 2021 Health Canada, Health Products and Food Branch (HPFB) Bilateral Meeting Program Virtual May 12, 2021 1:00 p.m. to 3:00 p.m. On this page Participants Meeting minutes Next meeting Participants IMC…

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