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Found 10 records similar to Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products

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

To ensure that sponsors of new drug submissions have 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 bioavailability and comparative pharmacodynamic studies used in support of the safety and efficacy of a drug.

Last Updated: Jun. 1, 2021
Date Published: Mar. 1, 2018
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, comparative bioavailability standards, comparative pharmacodynamic studies, Food and Drug Regulations, safety of a drug
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

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

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

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

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
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
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