00000nam 2200000zi 4500 9.945564 CaOODSP 20251006164304 m o d f cr mn||||||||| 241126e202510##onc ob f000 0 eng d 9780660746609 CaOODSP eng rda CaOODSP n-cn--- H164-277/2025E-PDF Guidance document : the management of drug submissions and applications. Ottawa, ON : Health Canada = Santé Canada, October 2025. ©2025 1 online resource (52 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice : gestion des présentations et des demandes de drogue. Includes bibliographical references (pages 44-45). "This guidance document gives direction and guidance when managing information submitted in accordance with the Food and Drugs Act and its regulations. This guidance is for sponsors and Health Canada staff from the following directorates and divisions: Medical Devices Directorate (MDD); Pharmaceutical Drugs Directorate (PDD); Marketed Health Products Directorate (MHPD); Business Facilitation and Modernization Directorate (BFMD); Biologic and Radiopharmaceutical Drugs Directorate (BRDD); Office of Submissions and Intellectual Property (OSIP) within MHPD; Non-Prescription Drug Evaluation Division (NDED) of the Natural and Non-prescription Health Products Directorate (NNHPD)"--Overview, page 1. Drug approval Canada. Pharmaceutical policy Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.945565 Guidance document : 2022 (CaOODSP)9.912786 PDF 1.30 MB https://publications.gc.ca/collections/collection_2025/sc-hc/H164-277-2025-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions-applications.html Pub.: 240651