Open Government Portal

Found 2972 records

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 pharmaceutical development ICH Topic Q8(R2)

This guidance is intended to assist sponsors in the collection and analysis of comparative clinical data for Inhaled Corticosteroid (ICS) …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document data requirements safety-and-effectiveness of subsequent entry inhaled Corticosteroid products treatment of asthma

Health Canada, through its Clinical Trials Database, is providing to the public a listing of specific information relating to phase …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: clinical trials database phase I II and III clinical-trials in patients source of information clinical-trials involving human human pharmaceutical-and-biological drugs

Through SAP, health care professionals may request access to drugs that are not currently authorized for sale in Canada to …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: special access programs access to drugs not-currently-authorized for sale patients life-threatening conditions conventional therapies unsuitable unavailable overview

If you're a health care professional, you can request a drug that is not available for sale in Canada through …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: special access programs access to drugs not-currently-authorized for sale patients life-threatening conditions conventional therapies unsuitable unavailable request a drug

This guidance document is specific to the "tamper-resistance" feature of controlled-release opioid products. It is intended for the pre-market review …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document tamper-resistance formulations opioid drug tamper-resistance controlled-release opioid products pre-market drug submissions

Through its Action Plan on Medical Devices, Health Canada is committed to continuing to provide Canadians with more information on …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: action plan medical devices medical device treatment-options more information medical devices use Regulatory Decision Summaries publishing RDSs new Class-III medical-device-licences

Through the special access program (SAP) for medical devices, health care professionals can access custom-made and unlicensed medical devices for …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: special access programs access to drugs not-currently-authorized for sale patients life-threatening conditions conventional therapies unsuitable unavailable request access-to medical-device

While hyperbaric oxygen therapy is recognized as an effective treatment for 14 specific conditions listed below, the operators of some …

Record Modified: Dec 2, 2023
Record Released: Dec 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: hyperbaric oxygen therapy effective treatment 14 specific conditions multiple sclerosis cerebral palsy cancer AIDS stroke migraine headaches no scientific proof

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: ICH E8(R1) general considerations clinical studies ICH Expert Working-Group consultation regulatory parties ICH Assembly