Health Canada RSS - Compliance and Enforcement, Drugs and Health Productshttps://www.canada.ca/content/dam/hc-sc/migration/hc-sc/rss/dhp-mps/compli-conform-eng.xmlHealth Canadahttps://www.canada.ca/en/health-canada.html2013-06-26T12:00:00-05:00https://www.canada.ca/en/health-canada.html/images/templates/wmms.gifhttps://www.canada.ca/en/health-canada.html/images/common/sm-rss.gifStay informed when new items, such as recalls of drugs and medical devices, guidance documents, policies and forms, are added to the Compliance and Enforcement section of the Health Canada website.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Drug Quality Surveillance Programhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/drug-quality-surveillance-program.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-02-22T11:30:00-05:002024-02-22T11:30:00-05:00Learn about the Drug Quality Surveillance Program, which monitors the quality of pharmaceutical products in Canada.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Consultation open for foreign building compliance with drug good manufacturing practices (GUI-0080)https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/consultation-guidance-0080.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-02-14T11:30:00-05:002024-02-14T11:30:00-05:00Health Canada is has opened consultation on How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080). The 90-day consultation period ends on May 15, 2024.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Canada’s regulations prevent drugs from being distributed outside the country if this could cause or worsen a shortagehttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-shortages/information-consumers/canada-regulations-prevent-distribute-drugs-outside-canada.htmlHealth Canada2024-02-08T10:30:00-05:002024-02-08T10:30:00-05:00Canada’s regulations prevent drugs from being distributed outside the country if it could cause or worsen a shortageThe material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Consultation period extended until April 26, 2023 for proposed agile regulations and guidance for licensing drugs and medical deviceshttps://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2023-03-06T16:00:00-04:002023-03-06T16:00:00-04:00The consultation period for the proposed Agile Regulations and Guidance for the Licensing of Drugs and Medical Devices has been extended by an additional 30 days. This consultation will now close to new input on April 26, 2023, at 11:59pm Eastern Standard Time (EST).The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Drug shortages in Canada: Information for consumers [2023-01-20]https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-shortages/information-consumers.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2023-01-20T19:45:00-05:002023-01-20T19:45:00-05:00Advice for consumers on what to do if a medication they want to buy is in shortageThe material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Consultation on proposed agile regulations and guidance for licensing drugs and medical devices [2022-12-16]https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2022-12-16T16:30:00-05:002022-12-16T16:30:00-05:00Health Canada is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These changes will continue to advance our modernization agenda and help to reduce regulatory irritants and roadblocks to innovation. We are seeking feedback on both the proposed regulations and on multiple guidance documents related to the proposal.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Updates to the Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 [2022-12-16]https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/food-drug-regulations-amendments-covid-19.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2022-12-16T16:45:00-05:002022-12-16T16:45:00-05:00Health Canada has updated our Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2023.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2022-12-02T15:30:00-05:002022-12-02T15:30:00-05:00Medical Devices Establishment License bulletin outlining the annual licence review process for 2023.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Changes made to list of non-prescription drugs: Notice of modificationhttps://canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/legislation-regulatory-amendments/incorporation-by-reference/lists-incorporated-by-reference/changes-made-list-non-prescription-drugs-notice-modification.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2022-10-28T15:30:00-05:002022-10-28T15:30:00-05:00The Regulatory Operations and Enforcement Branch has amended the List of non-prescription drugs for which the testing requirements set out in subsections C.02.019 (1) and (2) of the Food and Drug RegulationsThe material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Notice: Clinical trials for medical devices and drugs relating to COVID-19 regulationshttps://canada.ca/en/health-canada/services/clinical-trials/notice-medical-devices-drugs-covid-19-regulations.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2022-03-02T19:00:00-05:002022-03-02T19:00:00-05:00Information on the regulations for clinical trials for medical devices and drugs relating to COVID-19 transition from the Interim Order.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Notice of updated guidance: Applications for COVID-19 drug clinical trials under the Regulationshttps://canada.ca/en/health-canada/services/clinical-trials/notice-updated-guidance-applications-covid-19-drug-regulations.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2022-03-02T19:00:00-05:002022-03-02T19:00:00-05:00Health Canada has updated and renamed the guidance document that was created for the interim orders No. 1 and No. 2 for COVID-19-related clinical trials for drugs.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Notice of updated guidance: Applications for COVID-19 medical device clinical trials under the Regulationshttps://canada.ca/en/health-canada/services/clinical-trials/notice-updated-guidance-applications-covid-19-medical-device-regulations.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2022-03-02T19:00:00-05:002022-03-02T19:00:00-05:00Health Canada has updated and renamed the guidance document that was created for interim orders No. 1 and No. 2 for COVID-19-related clinical trials. The new name of this document for medical devices is the Guidance on applications for COVID-19 medical device clinical trials under the Regulations.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Notice: Period reduced for keeping clinical trial records for drugs and natural health productshttps://canada.ca/en/health-canada/services/clinical-trials/notice-period-reduced-keeping-records-drugs-natural-health-products.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2022-03-02T19:00:00-05:002022-03-02T19:00:00-05:00Information on Health Canada reducing the period for keeping clinical trial records for drugs and natural health products from 25 years to 15 years.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Notice: Regulations amending certain regulations concerning drugs and medical devices (shortages)https://canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/notice-amending-regulations-drugs-medical-devices-shortages.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2022-03-02T12:00:00-05:002022-03-02T12:00:00-05:00The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were made on 03-02, 2022. They amend the Food and Drug Regulations and Medical Devices Regulations that were published on 09-01-2022. They extend and modify certain measures already in place through 2 interim orders (IOs). They have been made to help monitor, prevent and mitigate shortages of key health products in Canada, including drugs and medical devices.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.Subscribe to MedEffect e-Noticehttps://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/stay-informed-medeffect-canada.html#subscribeHealth Canadahttps://www.canada.ca/en/health-canada.html2022-03-01T10:08:00-05:002022-03-01T10:08:00-05:00MedEffect e-Notice is a free service that sends health product alerts right to your e-mail inbox. Advisories and recalls are an important source of information regarding the post-market safety and effectiveness of health products.The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.