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47484 records

Depending on its ingredients, a dental plaque-disclosing product can be regulated as a drug under the F&DA either as a …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: classification dental-plaque-disclosing products products as drugs pharmaceutical drug Drug Identification Number natural health product Natural Product Number

Health Canada is pleased to announce the adoption of the ICH guidance E16: Biomarkers Related to Drug or Biotechnology Product …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document biomarkers drug biotechnology product development context structure format qualification submissions ICH Topic E16

The Access to Information Act (the Act) gives Canadian citizens, permanent residents and all individuals and corporations present in Canada …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Impact Assessment Agency of Canada
Formats: HTML
Keywords: ATIP Access to Information Act Annual Report

Given the fast pace of innovation in digital health technologies specifically in relation to medical devices, Health Canada is undertaking …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: digital health technologies healthcare system needs Wireless Medical Devices mobile medical apps telemedicine software as a medical-device SaMD AI cybersecurity medical-device interoperability

Health Canada has implemented the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: E2D …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: ICH guidance reporting adverse reactions to-health-products marketed health products E2D post-approval safety data-management

Health Canada is initiating the transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: improving access access-to medical-devices information medical device categorization Global Medical-Device Nomenclature GMDN medical devices innovations

In agreeing to apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document certificates of supplementary-protection new pharmaceutical products eligible patent pharmaceuticals biologics veterinary drugs

This guidance was developed by the appropriate ICH Expert Working Group and was subject to consultation by the regulatory parties, …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document E10 choice of control-group clinical trials

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document ethnic factors acceptability-of foreign clinical data ICH Topic E5(R1)

The purpose of this guidance document is to provide manufacturers of Class IV Human Immunodeficiency Virus (HIV) rapid diagnostic tests …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document guidance for manufacturers human immunodeficiency virus HIV rapid diagnostic tests RDTs point of care self-testing