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Found 10 records similar to Notice - Revision to Guidance Document: Submission of Pharmacogenomic Information

Federal

Health Canada is revising the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This document provides sponsors and Health Canada staff of the Therapeutic Products Directorate, the Biologic and Radiopharmaceutical Drugs Directorate, the Natural and Non-Prescription Health Products Directorate (Non-Prescription Drugs Evaluation Division), and the Marketed Health Products Directorate with operational direction and guidance regarding the way in which drug submissions, applications or post-market documents submitted to Health Canada are managed.

Last Updated: Dec. 29, 2021
Date Published: Jul. 7, 2021
Organization: Health Canada
Formats: HTML
Keywords:  revising guidance document, drug submissions, drug applications, post-market documents submissions, operational direction
Federal

Health Canada and the U.S. Food and Drug Administration (FDA) are holding joint public consultation meetings on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines currently under development. The aim of this initiative is to hold public consultation meetings prior to each bi-annual ICH face-to-face meeting, in order to seek input on certain regulatory aspects that could be beneficial for the harmonisation of ICH guidelines.

Last Updated: Dec. 29, 2021
Date Published: Aug. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  HC, USA Food and Drug Administration, Joint Public Consultation, International Council for Harmonisation, ICH, Technical Requirements, Pharmaceuticals for Human Use
Federal

Health Canada Revised Guidance Document - Acetaminophen Labelling Standard

Last Updated: Jun. 1, 2021
Date Published: Sep. 15, 2016
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, revised, acetaminophen labelling standard
Federal

The Periodic Benefit-Risk Evaluation Report (PBRER) described in this Guideline is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the International Conference on Harmonisation (ICH) regions. This Guideline defines the recommended format and content of a PBRER and provides an outline of points to be considered in its preparation and submission.

Last Updated: Jul. 7, 2021
Date Published: Sep. 17, 2013
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, periodic benefit-risk evaluation report, PBRER, International Conference on Harmonisation, ICH, Topic E2C(R2), reporting on marketed products
Federal

The Guidance Document: Management of Drug Submissions and Applications (MDSG) gives sponsors and Health Canada staff operational direction and guidance when managing information submitted in accordance with the Food and Drugs Act and its Regulations.

Last Updated: Jul. 7, 2021
Date Published: May 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, management of drug submissions and applications, sponsors, operational direction, managing information submitted during drug submissions and applications
Federal

This guidance document applies to all biologic drug submissions where the sponsor seeks authorization for sale based on demonstrated similarity to a previously approved biologic drug and relies, in part, on prior information regarding that biologic drug in order to present a reduced clinical and non-clinical package as part of the submission.

Last Updated: Jun. 7, 2022
Date Published: Dec. 13, 2021
Organization: Health Canada
Formats: HTML
Keywords:  biosimilar, biosimilar biologic drugs, information-and-submission requirements, authorization for sale, reduced clinical-and-non-clinical package
Federal

For the purpose of this guidance document, Health Canada has determined that certain submissions and applications involving human or disinfectants drugs may be submitted for administrative processing as they do not contain scientific data.

Last Updated: Sep. 17, 2020
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Administrative process of submission and application, submission and application of human and disinfectant drugs.
Federal

Health Canada is pleased to announce the release of five associated revised draft guidance documents on Post-Notice of Compliance (NOC) Quality Changes for pharmaceutical, biologic and radiopharmaceutical drugs for human use, for stakeholder consultation.

Last Updated: Dec. 29, 2021
Date Published: Jul. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  draft revised guidance, post-notice of compliance, changes for pharmaceutical, changes for biologic, changes for radiopharmaceutical, drugs for human-use, for stakeholder consultation
Federal

Health Canada is pleased to announce the fourth publication of the Guidance Document: Certificates of Supplementary Protection.

Last Updated: Dec. 29, 2021
Date Published: May 18, 2018
Organization: Health Canada
Formats: HTML
Keywords:  certificates of supplementary-protection, guidance document, certificates-supplementary-protection regulations, CSP Regulations
Federal

Guidance Document.

Last Updated: Jun. 7, 2022
Date Published: Nov. 3, 2015
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data, Sample Coding Categories, ICH Topic E15
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