Open Government Portal

Found 10 records similar to Guidance for Industry - Priority Review of Drug Submissions

Federal

Present the list of new drug submissions (NDSs) that are currently being reviewed.

Last Updated: Sep. 17, 2020
Date Published: Oct. 23, 2016
Organization: Health Canada
Formats: HTML
Keywords:  Drug submission, submissions under review, drug and health product review and approval.
Federal

How to access a list of generic drug submissions currently under review.

Last Updated: Sep. 17, 2020
Date Published: Nov. 29, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Drug submission, generic submissions under review, drug and health product review and approval.
Federal

Modified requirements for COVID-19 drugs allow for the filing of rolling submissions (section C.08.002(2.3) of Canada's Food and Drug Regulations). The ability to review data from early development while later-stage clinical trials are taking place helps to expedite the regulatory review process.

Last Updated: Jul. 28, 2022
Date Published: Oct. 29, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, COVID-19 drugs, market authorization requirements, drug manufactured, sold, regulatory process, rolling submissions-and-reviews
Federal

This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for the people of Canada will be faster access to drugs, including drugs for rare diseases.

Last Updated: Sep. 17, 2020
Date Published: Feb. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Priority review, faster access to drugs, health care system needs.
Federal

This guidance document provides clarification to submission sponsors on how to comply with (Veterinary Drugs Directorate of Health Canada) VDD's policies, governing statutes and regulations.

Last Updated: Jul. 8, 2021
Date Published: Nov. 6, 2009
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, industry, sponsors, management of regulatory submissions, Veterinary Drugs Directorate of Health Canada, VDD, VDD's policies
Federal

For eligible submissions accepted into review on or after October 1, 2018, the submission 'class' added to the Lists of submissions currently under review.

Last Updated: Sep. 17, 2020
Date Published: Nov. 29, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Submission class, submissions under review, drug and health product review and approval.
Federal

This Guidance Document is to be used in the preparation of Veterinary Drug Submissions for presentation to Health Canada. Some sections of this Guidance Document are general in nature. Therefore, this Guidance Document should be used in conjunction with the complete Food and Drugs Act and Regulations, and with specific Health Canada Policies and Guidance Documents applicable to veterinary drugs.

Last Updated: Jul. 8, 2021
Date Published: Mar. 2, 2007
Organization: Health Canada
Formats: HTML
Keywords:  Guidance for industry, veterinary new drug submissions, preparation of veterinary new drug submissions, Food and Drugs Act and Regulations, policies on veterinary drugs.
Federal

Health Canada's drug products fact sheet describes how drugs are reviewed in Canada including how drugs are developed and submitted for authorization to conduct clinical trial.

Last Updated: Sep. 17, 2020
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Drug review, priority review, fast-track, life-saving drugs, expedited, and authorization for clinical trial.
Federal

This guidance document is intended to provide sponsors with an outline of the chemistry and manufacturing, clinical, and human safety requirements for the filing of the following submission types with the Veterinary Drugs Directorate (VDD): Abbreviated New Drug Submission (ANDS); Changes to ANDS - Supplemental Abbreviated New Drug Submission (SANDS) and Notifiable Change (NC).

Last Updated: Jul. 8, 2021
Date Published: Feb. 8, 2010
Organization: Health Canada
Formats: HTML
Keywords:  Guidance for industry, veterinary abbreviated new drug submissions, preparation of veterinary abbreviated new drug submissions, supplemental abbreviated new drug submission, notifiable change, generic drugs, chemistry and manufacturing, clinical, and human safety requirements
Federal

Following several successful joint reviews between Australia, New Zealand and Canada, there has been interest by others within industry to explore this as a model for bringing new veterinary drug products to market. Industry has been keen to understand how to initiate discussions and how the overall process would work. This document is therefore provided as guidance for industry about the joint review process for veterinary drugs.

Last Updated: Jul. 8, 2021
Date Published: Feb. 12, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Guidance, veterinary drug, veterinary drug joint reviews
Date modified: