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Found 10 records similar to Drug and Health Product Submissions Under Review (SUR)

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

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 aims to articulate Health Canada's expectations and generate a level of consistency regarding the interpretation of the Priority Review of Drug Submissions policy and the filing of a Priority Review request. Additional clarification of the process by which the Priority Review request is assessed is provided.

Last Updated: Jul. 7, 2021
Date Published: Jul. 6, 2012
Organization: Health Canada
Formats: HTML
Keywords:  Guidance for industry, priority review of drug submissions, interpretation of the priority review of drug submissions policy, priority review request
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

The purpose of this guideline is to provide sponsors of New Drug Submissions (NDSs) and related submissions (responses to information requests during the review, Responses to Notices of Deficiency or Non-Compliance (NODs/NONs), Supplemental New Drug Submissions (SNDSs), and Notifiable Changes (NCs)including Clinical Trial Applications (CTA) with approaches that acceptably meet the regulatory requirements that apply to the "Quality" (chemistry and manufacturing) portions of submissions.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  radiopharmaceuticals, schedule C drugs, quality-Information for Radiopharmaceuticals, quality-Information-summary, certified product information
Federal

This document is intended to describe the appropriate mechanisms to address drug submission-related disputes.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  reconsideration of decisions, human drug submissions, drug submission-related disputes
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

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

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

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
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