Open Government Portal

Found 2972 records

This page provides information to assist veterinary drug manufacturers (sponsors) in preparing a well-structured DIN submission to facilitate screening and …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Drug Identification Number DIN veterinary DIN submissions veterinary drug manufacturers

Priority Review is a fast-track status granted to eligible new drug submissions for human use, following review and approval of …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: priority review submissions drug submissions Therapeutic Products fast-track status eligible new-drug submissions drug sponsor drug review queue accelerated review review target 180 days

Administrative Corrections to Health Canada's Priority Review Documents. Administrative changes were made to the French and Englishs version of the …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: policy of priority-review drug submissions policy administrative changes

This document introduces Health Canada's initiative to publicly release clinical information concerning the safety and efficacy of drugs and safety …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: publicly release clinical-information clinical-information drug submissions medical device applications safety-and-efficacy of drugs safety-and-effectiveness of medical-devices

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

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 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 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

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

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