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Scientific/Expert Advisory Panels Health Canada uses ad hoc scientific/expert advisory panels to provide medical/technical/scientific advice and recommendations on specific drug and medical device issues. Members are appointed by Health Canada. Only our current active panels are…

Projects Look-Alike Sound-Alike Health Products Summary Basis of Decision (SBD) Product Monograph Page details 2014-04-15

Notice of Compliance - Drug Products Definition : A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations . Notices of…

Drug products legislation and guidelines Acts and Regulations The Pharmaceutical Drugs Directorate ( PDD ) applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs offered for sale in Canada are safe, effective…

International Project Orbis [2021-04-16] Access Consortium [2017-12-28] International Council for Harmonisation (ICH) International Cooperation on Cosmetic Regulation (ICCR) Page details 2022-10-11

Health Canada's Clinical Trials Database Health Canada, through its Clinical Trials Database, is providing to the public a listing of specific information relating to phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source…

Fees for human drugs Information for the pharmaceutical industry about fees related to human drugs, with links to supporting guidance and forms. On this page Fee to evaluate human drug submissions Master file fees Fee to examine an application for an establishment licence Fee for…

Fact Sheets – Drug products Health Canada approves updates to Mifegymiso prescribing information: Ultrasound no longer mandatory [2019-08-23] Access to Generic Drugs in Canada [2018-05-02] How Drugs are Reviewed in Canada [2015-02-12] Fact sheet on Drug Shortages [2013-09-13]…

Association Meetings Health Canada meets on a regular basis with industry, research, and healthcare professionals' associations to exchange information and discuss issues. Pharmaceutical Drugs Directorate (PDD) Bilateral Meeting Program Please note that only meeting notes from…

Applications and Submissions - Drug Products All drug submissions must undergo rigorous scrutiny and fully satisfy all scientific requirements under the Food and Drug Regulations before any drug can be marketed in Canada. This section provides information about all the tools…