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Found 10 records similar to Guidance document: Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical 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

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

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

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

Clinical Trial Applications for pharmaceutical (Schedule F), radiopharmaceutical (Schedule C) and biological (Schedule D) drugs are all regulated under Part C, Division 5 of the Food and Drug Regulations, and therefore all must adhere to the same regulatory requirements. However, biological drugs carry additional risks associated with complexity and variability in manufacturing.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Clinical Trial Applications, CTA for Biologics, CTA Radiopharmaceuticals, biological drugs
Federal

The NOC is issued to a manufacturer following the satisfactory review of a submission for a new drug, and signifies compliance with the Food and Drug Regulations. The database is updated nightly and contains NOC information on human drugs from January 1, 1994 to date. It also contains NOC information on Veterinary drugs from September 19, 2000 to date.

Last Updated: Feb. 24, 2022
Date Published: Dec. 18, 2017
Organization: Health Canada
Formats: XML JSON HTML
Keywords:  NOC, veterinary drugs, DIN
Federal

On December 13, 2017, Health Canada published the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs in Dosage Form Listed in Schedule C to the Food and Drugs Act) in Canada Gazette, Part II. The objective of this regulatory amendment is to apply to Schedule C Drugs (radiopharmaceuticals and kits), the requirement to have a Drug Identification Number (DIN) in order for a drug to be sold in Canada. Along with the new requirement for all Schedule C drugs to have a DIN, the labelling requirements have also been updated to reflect the new requirement: instead of requiring the Establishment Licence number to be on the label, there will now be a requirement for the DIN to be on the label.

Last Updated: Jul. 6, 2021
Date Published: May 5, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, DIN, drug identification numbers, schedule C drugs, radiopharmaceuticals and Kits, regulatory amendment, Food and Drug Regulations, drugs in dosage form, the requirement
Federal

The publication of the National Occupational Classification (NOC) 2021 is the thirtieth anniversary of the standard occupational classification system and it introduces a major structural change. The NOC 2021 Version 1.0 overhauls the "Skill Level" structure by introducing a new categorization representing the degree of Training, Education, Experience and Responsibilities (TEER) required for an occupation. The NOC 2021 Version 1.0 also introduces a new 5-digit hierarchical structure, compared to a 4-digit hierarchical structure in the previous versions of the classification. The NOC has been developed and maintained as part of a collaborative partnership between Employment and Social Development Canada and Statistics Canada.

Last Updated: Dec. 9, 2021
Date Published: Sep. 21, 2021
Organization: Statistics Canada
Formats: HTML CSV
Keywords:  Classification, Classification codes, Classification systems, Industrial classification, Business statistics, Industry - Standard classifications
Federal

The purpose of this document is to provide guidance to sponsors to facilitate compliance with the labelling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act as well as related provisions of the Food and Drug Regulations and the Controlled Drugs and Substances Act.

Last Updated: Jul. 7, 2021
Date Published: Sep. 15, 2015
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, labelling requirements, labelling of pharmaceutical drugs, drugs for human use, Food and Drugs Act
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