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The Guidance Document: Fees for the Review of Drug Submissions and Applications has been updated. The Document Change Log has …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice updates guidance document fees for review drug submissions-and-applications

The attached policy has been developed to provide for the filing of Supplemental New Drug Submissions, Supplemental Abbreviated New Drug …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: policy issues supplemental new-drug-submissions supplemental abbreviated-new-drug-submissions changes-and-cross-referenced submissions

This document is intended to provide Industry with guidance for the preparation of drug submissions for Biotechnological/ Biological Products. It …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance for industry quality information drug submissions CTD Format biotechnological biological biotech products

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

Appearance by the Minister of Employment, Workforce Development and Disability Inclusion, Carla Qualtrough, and Deputy Minister Tremblay, before the Standing …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Employment and Social Development Canada
Formats: HTML
Keywords: HUMA committee briefing binder: Appearance of Minister Qualtrough and Deputy Minister Tremblay – February 7 2023

Appearance by the Minister of Minister of Families, Children and Social Development, Karina Gould, before the Standing Committee on Human …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Employment and Social Development Canada
Formats: HTML
Keywords: ESDC HUMA committee binder proactive disclosure minister famille children social development karina gould appearance study ...

Briefing package for the Privacy Commissioner of Canada as witness before the Standing Committee on Access to Information, Privacy, and …

Record Modified: Sep 3, 2023
Record Released: Sep 1, 2023
Publisher: Office of the Privacy Commissioner of Canada
Formats: HTML
Keywords: briefing binder committee ETHI Main estimates budget privacy

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