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Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: …
Federal

Significant new requirements are presented in the guidance document (i.e. stability studies on three batches of product for existing drugs, …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: publication of guidance-document quality guidance chemistry and manufacturing new drug submissions NDSs abbreviated-new drug submissions ANDSs
Quality Overall Summary - Chemical Entities (Applications for Drug Identification Number Submissions) …
Federal

The Quality Overall Summary (QOS) is a summary of the Quality Body of Data. This QOS-CE (DINA) template can be …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: quality overall summary chemical entities applications for DIN submission DIN submissions
Service Standards for Drug Submission Evaluations (Pharmaceuticals and Biologic Products) under the …
Federal

Service Delivery Standards.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Service Standards drug submission evaluations pharmaceuticals-and-biologic products Service Delivery Standards
Service Standards for Veterinary Drug Submission Evaluations under the Food and Drug …
Federal

Service Standards for Veterinary Drugs.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: service standards veterinary-drug submission evaluations Food-and-Drug Regulations
Drug Identification Number (DIN)
Federal

A Drug Identification Number (DIN) is a computer-generated eight digit number assigned by Health Canada to a drug product prior …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Drug Identification Number DIN
Drug identification numbers (DINs) - guidance documents
Federal

Find information on drug identification numbers, and guidance documents and forms to help you apply for one.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Drug identification numbers DINs guidance documents application forms
Drug product announcements
Federal

COVID-19 and other drug product announcements until July 2023.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug product announcements COVID-19 vaccine announcements
Drug products legislation and guidelines
Federal

Acts and regulations, Health Canada guidance documents and policies related to pharmaceutical drugs and medical devices. The Pharmaceutical Drugs Directorate …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: drug products legislation Food-and-Drug Regulations Food-and-Drugs Act interim orders notices canada gazette memorandum of understanding schedule f guidance documents policies pharmaceutical drugs safe ...
Fact Sheets – Drug products
Federal

List of Health Canada information sheets covering topics related to drug products.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: fact sheets information sheets drug products prescription drugs prescription medicines pharmaceutical products
Fact Sheets – Medical devices
Federal

Health Canada fact sheets related to medical devices.

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: fact sheets medical devices