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Found 10 records similar to Notice: Publication of the Guidance Document: Certificates of Supplementary Protection

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

The Guidance Document: Management of Drug Submissions and Applications (MDSG) gives sponsors and Health Canada staff operational direction and guidance when managing information submitted in accordance with the Food and Drugs Act and its Regulations.

Last Updated: Jul. 7, 2021
Date Published: May 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, management of drug submissions and applications, sponsors, operational direction, managing information submitted during drug submissions and applications
Federal

Health Canada is pleased to announce the release of five associated revised draft guidance documents on Post-Notice of Compliance (NOC) Quality Changes for pharmaceutical, biologic and radiopharmaceutical drugs for human use, for stakeholder consultation.

Last Updated: Dec. 29, 2021
Date Published: Jul. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  draft revised guidance, post-notice of compliance, changes for pharmaceutical, changes for biologic, changes for radiopharmaceutical, drugs for human-use, for stakeholder consultation
Federal

The pilot for Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format concluded on August 31, 2019. Health Canada is pleased to announce that the pilot was successful. Therefore, implementation of Clinical Trials regulatory activities in eCTD format will begin immediately.

Last Updated: Jun. 2, 2021
Date Published: Feb. 19, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Notice, implementation of eCTD, electronic common technical document, clinical trial regulatory activities
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

Canada’s obligations under the North American Free Trade Agreement and the Agreement on Trade-Related Aspects of Intellectual Property Rights require the granting of protection for undisclosed test or other data necessary to determine the safety and effectiveness of a pharmaceutical product which utilizes a new chemical entity, the origination of which involved considerable effort.

Last Updated: Jul. 5, 2021
Date Published: Oct. 7, 2011
Organization: Health Canada
Formats: HTML
Keywords:  Data protection, Food and Drug Regulations, North American Free Trade Agreement, agreement, trade, intellectual property rights, undisclosed test, safety and effectiveness, pharmaceutical product
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

The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were made on September 1st, 2021. They amend the Food and Drug Regulations and Medical Devices Regulations and are published in Canada Gazette, Part II.

Last Updated: Sep. 24, 2021
Date Published: Sep. 1, 2021
Organization: Health Canada
Formats: HTML
Keywords:  drug regulations, medical devices regulation, amending certain regulations, drugs shortages, medical devices shortages
Federal

Health Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation of medical devices by increasing post-market surveillance authorities.

Last Updated: Oct. 21, 2022
Date Published: Sep. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Medical Devices Regulations, regulatory changes, new regulations, post-market surveillance, risk management
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
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