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About good pharmacovigilance practices (GVP) inspections Any drugs sold to Canadians must remain safe and effective after they are approved for prescription and sale. Learn about good pharmacovigilance practices (GVP) and how Canada conducts GVP inspections. On this page GVP…
About drug inspections Before drugs can be sold to Canadians, they must meet high safety and quality standards. This is the case for drugs made in Canada or abroad. Learn about drug inspections, how the Government of Canada (GC) conducts them and our licensing practices. On this…
About inspections of clinical trials for human drugs Canada aims to reduce the risks to participants who enrol in clinical trials. Learn about clinical trial inspections and how we conduct them. On this page Clinical trial inspections Who is involved What inspectors look for…
Chemical risk assessments Learn about chemical substance risk assessments under the Chemicals Management Plan. On this page What is the Chemicals Management Plan? What is a chemical risk assessment? How is a chemical risk assessment done? Why are chemical risk assessments…
Regulatory decision summaries of drugs and health products Understand the decisions to approve or not approve the sale of drugs and medical devices in Canada. The reasons for these decisions are in the regulatory decision summaries (RDSs). RDSs are posted for positive decisions…
Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs) July 5, 2012 (PDF Version - 561 K) On this page: Notice Guidance Document…
Drug product announcements Current (2026) April New website for health product shortages [2026-04-10] Final notice: Classification of topical products containing human-derived exosomes, human extracellular vesicles, or human cell-conditioned media [2026-04-10] Consultation:…
Guidance Document - Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act 1. Request for disclosure of confidential business information (CBI) 2. Disclosure of confidential business information 3. Completed requests for disclosure of…
Public Release of Clinical Information: consultation Current Status: Public consultation on making clinical information about the safety and efficacy of drugs and medical devices available to the public is closed. The guidance document and related documents have been finalized…
Cheminement des évaluateurs Le Cheminement des évaluateurs est un ensemble complet de programmes d'apprentissage et de perfectionnement visant à soutenir le développement des compétences des pairs évaluateurs, peu importe l'étape de carrière, l'expertise et le contexte (p. ex.…
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