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Found 10 records similar to Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products

Federal

Evidence of Good Manufacturing Practices (GMP) for drug submissions. The goal of this revision is to better align the drug submission screening and review process with the Drug Establishment Licence (DEL) process. This should allow sponsors to make timely drug submissions while still providing adequate assurance of an establishment’s commitment to quality.

Last Updated: Jul. 8, 2021
Date Published: Feb. 10, 2017
Organization: Health Canada
Formats: HTML
Keywords:  drug submission, submission filing requirements, good manufacturing practices, GMP, drug establishment licences
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’s Veterinary Drugs Directorate (VDD) is clarifying the expectations for the information about Good Manufacturing Practices (GMP) status that should accompany veterinary drug submissions.

Last Updated: Jul. 8, 2021
Date Published: Feb. 16, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Notice, submission filing recommendations, veterinary drugs, good manufacturing practices, drug establishment licences
Federal

The purpose of this document is to provide sponsors of new drug submissions and abbreviated new drug submissions with the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations, with respect to comparative pharmacokinetic studies, with emphasis on in vivo comparative pharmacokinetic studies.

Last Updated: Jun. 2, 2021
Date Published: Feb. 27, 2020
Organization: Health Canada
Formats: HTML
Keywords:  draft guidance, consultation, comparative pharmacokinetic studies, orally inhaled products, sponsors of new drug submissions, abbreviated new drug submissions, Food and Drug Regulations
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

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

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

When a company decides it would like to sell a drug or vaccine in Canada, it files a submission with Health Canada. A new drug submission contains detailed scientific information about the drug's safety, efficacy and quality. Health Canada scientific reviewers evaluate data to assess the potential benefits and risks of a drug or vaccine. They also review the information that will be provided to health care practitioners and consumers about the product.

Last Updated: Aug. 26, 2021
Date Published: Jul. 27, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, drugs, vaccines, drug and vaccine authorizations, new drug submissions, scientific information, drug's safety, efficacy and quality, scientific reviewers
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

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
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