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Found 10 records similar to Notice: Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)

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

Division 1A of Part C of the Regulations applies to COVID-19 drugs. A person must hold a drug establishment licence (DEL) authorizing any activities conducted with respect to COVID-19 drugs.

Last Updated: Jul. 29, 2021
Date Published: Jun. 23, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, COVID-19 drug, amendement, Food and Drug Regulations, drugs, manufacturers, submission, notice of compliance
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 Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (that is [i.e.], new drug and abbreviated new drug submissions) of changes in Health Canada's comparative bioavailability requirements for drug products which exhibit large pharmacokinetic within-subject variation in extent of absorption, as measured by area under the concentration versus time curve (AUC).

Last Updated: Jun. 1, 2021
Date Published: Apr. 18, 2016
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, drug submissions, new drug submissions, policy on bioequivalence standards, highly variable drug products, comparative bioavailability requirements, pharmacokinetic
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 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

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

The purpose of this guidance is to define the Common Technical Document (CTD) format of drug submissions which rely on comparative bioavailability studies to establish safety and efficacy. This guidance also references some of the technical requirements related to the conduct and analysis of such studies.

Last Updated: Jun. 1, 2021
Date Published: Jan. 27, 2011
Organization: Health Canada
Formats: HTML
Keywords:  guidance for industry, comparative bioavailability, drug submissions, common technical document, CTD format, sfety and effectiveness, Food and Drug Regulations
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

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.
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