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Found 10 records similar to Notice: Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Entry Inhaled Corticosteroid Products Used for the Treatment of Asthma

Federal

This guidance is intended to assist sponsors in the collection and analysis of data for Steroid Nasal products for use in the treatment of allergic rhinitis, in order to meet the safety and effectiveness requirements under Part C, Division 8 of the Food and Drug Regulations.

Last Updated: Jun. 1, 2021
Date Published: Sep. 19, 2011
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, data requirements, safety and effectiveness, steroid nasal products, treatment of allergic rhinitis, Food and Drug Regulations
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

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Keywords:  draft guidance, consultation, comparative pharmacokinetic studies, orally inhaled products, sponsors of new drug submissions, abbreviated new drug submissions, Food and Drug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 notice outlines the safety and effectiveness requirements for Class I medical masks and face coverings with anti-microbial claims. This notice is for manufacturers using either an interim order (IO) authorization or medical device establishment licence (MDEL) to manufacture, import or sell these devices in Canada.

Last Updated: Jun. 30, 2021
Date Published: Apr. 21, 2021
Organization: Health Canada
Formats: HTML
Keywords:  technical requirements, technical requirements for anti-microbial claims, medical masks, safety and effectiveness requirements, Class I medical masks, face coverings
Federal

This guidance document outlines the information considered necessary to support the safety and effectiveness of contact lens disinfectants, which are regulated as medical devices under the Medical Devices Regulations.

Last Updated: Jul. 6, 2021
Date Published: Mar. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, safety and effectiveness requirements, contact lens, disinfectants, medical devices, medical device regulations
Federal

This guidance document outlines the information considered necessary to support the safety and effectiveness of chemical products that are represented for use as high-level disinfectants and sterilants on reusable semi-critical and critical medical devices, which are regulated as medical devices under the Medical Devices Regulations.

Last Updated: Jul. 6, 2021
Date Published: Mar. 16, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, safety and effectiveness requirements, high-level disinfectants and sterilants, reusable, semi-critical, critical, medical devices, safety and effectiveness of chemical products, reusable semi-critical
Provincial

Asthma prevalence in Nova Scotia. Includes the following data fields: Year, Management Zone, Sex, Age Group, Population, Asthma Prevalence Count, Crude Prevalence Rate %

Last Updated: May 3, 2022
Date Published: Jun. 29, 2018
Organization: Government of Nova Scotia
Formats: XML HTML RDF CSV other RSS
Keywords:  asthma, crude prevalence, chronic disease
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 and the U.S. Food and Drug Administration (FDA) are holding joint public consultation meetings on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines currently under development. The aim of this initiative is to hold public consultation meetings prior to each bi-annual ICH face-to-face meeting, in order to seek input on certain regulatory aspects that could be beneficial for the harmonisation of ICH guidelines.

Last Updated: Dec. 29, 2021
Date Published: Aug. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  HC, USA Food and Drug Administration, Joint Public Consultation, International Council for Harmonisation, ICH, Technical Requirements, Pharmaceuticals for Human Use
Federal

Health Canada is pleased to announce the fourth publication of the Guidance Document: Certificates of Supplementary Protection.

Last Updated: Dec. 29, 2021
Date Published: May 18, 2018
Organization: Health Canada
Formats: HTML
Keywords:  certificates of supplementary-protection, guidance document, certificates-supplementary-protection regulations, CSP Regulations
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