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Proposals to Amend the Food and Drug Regulations with respect to radiopharmaceuticals September 20, 2011 Dear stakeholders, Health Canada is considering two regulatory amendments which may be of interest to your organization. This letter is meant to inform you about the status of…

Canada Gazette Part I – Biologics, Radio-pharmaceuticals & Genetic Therapies The following proposed regulatory amendments and Regulatory Impact Analysis Statement (RIAS) were recently pre-published in the Canada Gazette Part I for public consultation. Readers are invited to…

Food labelling coordination From: Canadian Food Inspection Agency , Health Canada Food Directorate Health Products and Food Branch The Canadian Food Inspection Agency (CFIA) and Health Canada committed to develop a strategy for coordinating future changes to food labelling…

Consultation: Proposed new guidance for Novel Food Regulations focused on plant breeding From: Health Canada Current status: Closed This consultation ran from March 25, 2021 to May 24, 2021. Summary of comments received during the public consultation Health Canada is seeking…

Infant formula and human milk fortifiers Learn about the limited supply of infant formula . Infant foods are foods that are represented for consumption by infants (persons who are under the age of one year). Health Canada assesses safety and nutritional adequacy of the following…

Medical Devices Action Plan: Progress report This update shows you the progress we have made on the Medical Devices Action Plan (MDAP), and points to areas where we will continue to deliver results to Canadians. On this page Medical Device Action Plan purpose and progress Improve…

Quality (chemistry and manufacturing) draft guidance: New Drug Submissions and Abbreviated New Drug Submissions Download in PDF format (1.08 MB, 75 pages) Organization: Health Canada Published: 2022-12-22 Date adopted: 10-30-2017 Effective date: 2018/01/30 Date updated:…

Draft guidance document: Labelling of pharmaceutical drugs for human use Download in PDF format (1.06 MB, 65 pages) Organization: Health Canada Date published: 2022-12-21 Date adopted: 11-01-2013 Effective date: 06-13-2015 Date revised: 12-17-2022 The following guidance document…

Regulatory cooperation - Canadian guidance on veterinary drug simultaneous reviews with the United States: Overview This guidance is a draft version for consultation purposes only. It is not to be implemented at this time. Overview Pre-submission Submission filing Review process…

List of conditions that threaten public health in Canada This list is defined in section C.08.001.1 of the Food and Drug Regulations, and incorporated by reference in: sections C.01A.005, C.01A.006 and C.01A.008 the definition of public health emergency drug in section C.08.001.1…