Open Government Portal

Found 10 records similar to Notice: Release of draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality, for stakeholder consultation

Federal

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to Section C.08.004 of the Food and Drug Regulations. This may include pharmaceuticals, biologics and radiopharmaceuticals for human use and pharmaceutical, radiopharmaceutical and certain biotechnological products for veterinary use.

Last Updated: Jul. 7, 2021
Date Published: Aug. 26, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Post-Notice of Compliance, NOC Changes, quality guidance, changes to new drugs, section C.08.004 of the Food and Drug Regulations, pharmaceuticals, biologics, radiopharmaceuticals, drugs for human use
Federal

After a new drug as defined in section C.08.001 of the Food and Drug Regulations has been granted a Notice of Compliance (NOC), it is not uncommon for sponsors to make changes to the drug. A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. Many of these changes may be made to improve the quality of the drug product or the efficiency of the manufacturing process, or they could be made for marketing considerations. Changes to the labelling of a drug product could include adding new indications, improving the management of risk for a product by adding warnings, limiting the target population or changing the dosage regime etc.

Last Updated: Jul. 7, 2021
Date Published: Aug. 27, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Post-Notice of Compliance, NOC Changes, framework document, changes to the drug, section C.08.004 of the Food and Drug Regulations
Federal

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use and pharmaceutical and certain biotechnological products for veterinary use, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.

Last Updated: Jul. 7, 2021
Date Published: Aug. 12, 2018
Organization: Health Canada
Formats: HTML
Keywords:  Post-notice of compliance, NOC changes, safety and efficacy document, changes to new drugs, section C.08.004 of the Food and Drug Regulations, pharmaceuticals, biologics, radiopharmaceuticals, human use
Federal

A post-NOC change is any change that is made to a new drug that has received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. Many of these changes may be made to improve the quality of the drug product or the efficiency of the manufacturing process, or they could be made for marketing considerations. Changes to the labelling of a drug product could include adding new indications, improving the management of risk for a product by adding warnings, limiting the target population or changing the dosage regime etc.

Last Updated: Jul. 7, 2021
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Post-Notice of Compliance, NOC Changes, framework document, pharmaceutical, biologic, radiopharmaceutical drugs, drugs for human use only
Federal

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.

Last Updated: Jul. 7, 2021
Date Published: Apr. 1, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, post-notice of compliance, NOC Changes, changes to new drugs, safety and efficacy document, pharmaceutical, biologic, radiopharmaceutical, drugs for human use
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

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

Classification of a therapeutic product determines whether it is regulated as a drug [that is (i.e.) pharmaceutical, biologic, natural health product] or a medical device. The purpose of this notice is to communicate Health Canada's current decision that non-medicated eyewashes should be regulated under the Natural Health Products Regulations (NHPR).

Last Updated: Sep. 9, 2021
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, Natural Health Products Reg ulations, NHPR, notice, classification of non-medicated eyewashes, non-medicated eyewashes, classification of a therapeutic product, regulated as a drug
Federal

Health Canada has adopted the International Conference on Harmonization (ICH) guideline Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories, ICH Topic E15.

Last Updated: Jun. 7, 2022
Date Published: Aug. 13, 2008
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, submission of Pharmacogenomic-Information
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
Date modified: