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Health Canada RSS - Drug Products, Drugs and Health Products
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Latest posts
Last updated 2 days ago
Implementation of International Council for Harmonisation (ICH) Q12 - Technical and regulatory considerations for pharmaceutical product lifecycle management: Notice
2 days ago
The Q12 Guideline provides a framework to facilitate the management of post-approval...
Health Canada implementation of the ICH E6(R3) guideline: Notice to stakeholders
2 days ago
The E6(R3) Guideline builds on key concepts outlined in ICH E8(R1) General...
Health Canada updates the guidance on expanded access clinical trials: Notice
16 days ago
This guidance document is meant for sponsors, health care providers and potential...
Summary Basis of Decision for Pavblu
18 days ago
Health Canada Summary Basis of Decision 2025-09-12. Pavblu, 2 mg/0.05 mL, aflibercept...
Summary Basis of Decision for Hepcludex
18 days ago
Health Canada Summary Basis of Decision 2025-09-29. Hepcludex, 2 mg bulevirtide/vial, powder...
Summary Basis of Decision for Isturisa
18 days ago
Health Canada Summary Basis of Decision 2025-08-18. Isturisa, osilodrostat phosphate, 1 mg...
Summary Basis of Decision for Yesafili
18 days ago
Health Canada Summary Basis of Decision 2025-08-22. Yesafili, aflibercept, 2 mg/0.5 mL...
Health Canada updates guidance on management of drug submissions and applications: Notice
18 days ago
Health Canada has updated its Guidance on managing drug submissions and applications...
Qualifying notice for Amtagvi (293019) [2025-10-01]
18 days ago
A Notice of Compliance with Conditions (NOC/c) is authorization to market a...
Consultation: Draft guidance on the plain language labelling regulations for prescription drugs [2025-09-25 – 2025-11-07]
24 days ago
Health Canada is consulting on updates to its plain language labelling for...
Updated: Regulatory enrolment process
about 1 month ago
Updated the REP Summary Table due to the updated Regulatory Transaction Template...
Health Canada and the Public Health Agency of Canada’s report on red tape reduction
about 1 month ago
Health Canada and the Public Health Agency of Canada have conducted a...