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Found 10 records similar to Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects

Federal

To provide sponsors of 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 (Regulations) with respect to comparative bioavailability studies used in support of the safety and efficacy of a drug.

Last Updated: Jun. 1, 2021
Date Published: Sep. 1, 2018
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, conduct and analysis, comparative bioavailability studies, pharmaceutically equivalent, data requirements and criteria
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Keywords:  draft guidance, consultation, comparative pharmacokinetic studies, orally inhaled products, sponsors of new drug submissions, abbreviated new drug submissions, Food and Drug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

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 guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 indicates that the plain language labelling requirements for mock-up labels and a brand name assessment package do not apply (C.08.002(2)(j.1) and C.08.002(2)(o)). Although not required, sponsors are invited to provide a brand name assessment should one be available.

Last Updated: Jul. 27, 2021
Date Published: Mar. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  coronavirus, COVID-19, pandemic, drugs, medications, vaccines, market authorization, licensing, importing or selling
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

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 guidance document provides sponsors of subsequent entry inhaled corticosteroid (ICS) products for the treatment of asthma with information on the comparative clinical data requirements in order to establish the safety and effectiveness of their products under Section C.08 of the Food and Drug Regulations.

Last Updated: Jun. 1, 2021
Date Published: Oct. 31, 2018
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, data requirements, safety and effectiveness, inhaled corticosteroid products, asthma, treatment of asthma, clinical data requirements
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). Before filing a submission for a rolling review, sponsors of clinical trials are expected to have gathered a certain level of evidence on the safety, quality and efficacy of their vaccine.

Last Updated: Jul. 27, 2021
Date Published: Mar. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  coronavirus, COVID-19, pandemic, drugs, medications, vaccines, market authorization, licensing, importing or selling
Federal

A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission. The NOC extract files contain Health Canada authorization dates for all drugs dating back to 1994 that have received an NOC. There are four types of NOCs: Biological, Prescription, Nonprescription and Veterinary.

Last Updated: Feb. 22, 2022
Date Published: Aug. 19, 2010
Organization: Health Canada
Formats: TXT
Keywords:  notice of compliance listings, notices of compliance with conditions
Federal

A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission. The NOC extract files contain Health Canada authorization dates for all drugs dating back to 1994 that have received an NOC. There are four types of NOCs: Biological, Prescription, Nonprescription and Veterinary.

Last Updated: Feb. 22, 2022
Date Published: Aug. 19, 2010
Organization: Health Canada
Formats: TXT
Keywords:  notice of compliance listings, notices of compliance with conditions
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