570 556 captures · dernière capture : 3 mai 2026
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386 223 captures · dernière capture : 14 avr. 2026
243 880 captures · dernière capture : 28 avr. 2026
Consultation: Draft guidance on decentralized clinical trials Current status: Open Opened on December 23, 2025, and will close to new input on February 21, 2026. Health Canada has drafted a guidance document on decentralized clinical trials . The draft guidance outlines…
Notice of amendment: Revisions to the Prescription Drug List for nicotine buccal pouches January 14, 2026 Our file number: 26-100067-342 The purpose of this notice of amendment is to announce that Health Canada has revised the qualifier of the "Nicotine or its salts" listing on…
Qualifying notice for Retevmo (298049) Pharmaceutical Drugs Directorate Holland Cross, Tower "B" 6th Floor, 1600 Scott Street Address Locator #3106B Ottawa ON K1A 0K9 Dossier ID: e233861 Control number: 298049 Eli Lilly Canada Inc [name of employee removed] Director-Global…
Forms: Applications and submissions for drug products For industry information about COVID-19, visit our COVID-19 Drugs and vaccines section. To use an electronic form, you must first download the form to your computer and then use Adobe Reader or Adobe Acrobat software, latest…
Regulatory enrolment process (REP) Subscribe to our RSS feed The regulatory enrolment process (REP) facilitates the filing and processing of regulatory information related to: company dossier and product regulatory activity regulatory transaction REP consists of web-based…
Qualifying notice for Voxzogo (290788) Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: e283698 Control number: 290788 [employee name removed] [employee title removed] BioMarin…
Qualifying notice for Ziihera (296499) Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: e287822 Control number: 296499 Jazz Pharmaceuticals Ireland Limited c/o [employee name…
Additional information to accompany the proposed Order providing for reliance on decisions of, or documents produced by, foreign regulatory authorities in respect of certain drugs: Notice Date issued: February 5, 2026 On December 20, 2025, Health Canada launched a 70-day…
Notice of consultation: Removing zuranolone from the Prescription Drug List (PDL) February 9, 2026 Our file number: 26-100533-438 This Notice of Consultation provides an opportunity to comment on the proposal to remove “zuranolone or its salts” from both the Human and Veterinary…
Qualifying notice for Hyrnuo (297051) Pharmaceutical Drugs Directorate Holland Cross, Tower "B" 6th Floor, 1600 Scott Street Address locator #3106B Ottawa ON K1A 0K9 Dossier ID: e290194 Control number: 297051 Bayer Inc c/o [name of employee removed] Regulatory Strategy Lead 2920…
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