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Found 10 records similar to Post-Notice of Compliance (NOC) Changes: Framework Document
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.
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.
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.
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.
Health Canada is pleased to announce the release of five associated revised draft guidance documents on Post-Notice of Compliance (NOC) Quality Changes for pharmaceutical, biologic and radiopharmaceutical drugs for human use, for stakeholder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.
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.
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.
The National Occupational Classification (NOC) 2016 Version 1.2 updates the National Occupational Classification 2016 Version 1.1. The NOC has been developed and maintained as part of a collaborative partnership between Employment and Social Development Canada and Statistics Canada. This update of the classification was completed in response to the legalization of cannabis for non-medical use. This has resulted in twenty five new job titles being created in NOC 2016 V1.2 to reflect new occupations in the cannabis industries.
The National Occupational Classification (NOC) 2016 updates the National Occupational Classification 2011. The NOC has been developed and maintained as part of a collaborative partnership between Employment and Social Development Canada and Statistics Canada. This update of the classification reflects ongoing occupational research and consultation to incorporate information on new occupations.
The NOC is the product of a partnership between Statistics Canada and Employment and Social Development Canada. The National Occupational Classification (NOC) is the nationally accepted taxonomy and organizational framework of occupations in the Canadian labour market. The basic principle of classification of the NOC is that of kind of work performed. The NOC 2011 updates both the National Occupational Classification 2006 of Employment and Social Development Canada and Statistics Canada's National Occupational Classification for Statistics (NOC-S) 2006.