Health Canada RSS - Drug Products, Drugs and Health Productshttps://www.canada.ca/content/dam/hc-sc/migration/hc-sc/rss/dhp-mps/prod-eng.xmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-01-30T10:30:00-05:00https://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 guidance documents, Summary Basis of Decisions for Drug Products, updates to the Registers of Innovative Drugs, policies and forms, are added to the Drug Products section of the 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.Appendix 1: Established acceptable intake (AI) limits for N-nitrosamine impuritieshttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/established-acceptable-intake-limits.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-28T14:45:00-04:002024-03-28T14:45:00-04:00Health Canada’s list of established Acceptable Intake limits for N-nitrosamines has been updated.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 Compliance (NOC) Data Extractshttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/database/data-extract.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-28T14:15:00-04:002024-03-28T14:15:00-04:00The data extract is a series of compressed ASCII text files of the Notice of Compliance (NOC) database.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.Updated Register of Certificates of Supplementary Protection and Applications https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-27T11:15:00-04:002024-03-27T11:15:00-04:00Listing of drugs pursuant to sub-section 120(1) of the Certificate of Supplementary Protection 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.Register of Innovative Drugshttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-21T14:55:00-04:002024-03-21T14:55:00-04:00A listing of drugs pursuant to sub-section C.08.004.1(9) of the Food and Drug 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.Updated Register of Certificates of Supplementary Protection and Applicationshttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-19T11:50:00-04:002024-03-19T11:50:00-04:00Listing of drugs pursuant to sub-section 120(1) of the Certificate of Supplementary Protection 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.Updated Generic Submissions Under Reviewhttps://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-18T16:00:00-04:002024-03-18T16:00:00-04:00This is a list of certain generic drug submissions currently under review. The Generic Submissions Under Review list includes the medicinal ingredient(s) and therapeutic area.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.Updated Submissions Under Reviewhttps://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-18T15:45:00-04:002024-03-18T15:45:00-04:00This is a list of certain drug submissions currently under review. The Submissions Under Review list includes the medicinal ingredient(s) and therapeutic area.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.Updated: Guidance on nitrosamine impurities in medicationshttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-15T14:55:00-04:002024-03-15T14:55:00-04:00This guidance document represents Health Canada's current thinking and recommendations on issues related to nitrosamine impurities in pharmaceutical, biological and radiopharmaceutical products for human use.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 Compliance (NOC) Data Extractshttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/database/data-extract.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-15T11:55:00-04:002024-03-15T11:55:00-04:00The data extract is a series of compressed ASCII text files of the Notice of Compliance (NOC) database.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.Certificates of Supplementary Protection (CSP) and Applicationshttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-12T10:10:00-04:002024-03-12T10:10:00-04:00Health Canada Summary Basis of Decision 2024-02-08. Evkeeza, evinacumab 150 mg/mL, solution, Ultragenyx Pharmaceutical, Inc. Submission Control Number 272688The 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.Product Monograph Brand Safety Updateshttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/label-safety-assessment-update/product-monograph-brand-safety-updates.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-11T12:00:00-04:002024-03-11T12:00:00-04:00Product Monograph Brand Safety Updates for Submissions cleared between 02-01-2024 and 02-29-2024The 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: Nomination call for members – Scientific Advisory Committee on Mental Health Disordershttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/scientific-expert-advisory-committees/mental-health-disorders/nomination-call-members.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-08T16:15:00-05:002024-03-08T16:15:00-05:00Health Canada is seeking nominations for members for the Scientific Advisory Committee on Mental Health Disorders (SAC-MHD). The Committee will provide scientific, medical and clinical advice pertaining to the evaluation and treatment of various mental health disorder to the Pharmaceutical Drugs Directorate (PDD).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.Updated Register of Certificates of Supplementary Protection and Applicationshttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-08T15:15:00-05:002024-03-08T15:15:00-05:00Listing of drugs pursuant to sub-section 120(1) of the Certificate of Supplementary Protection 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.Register of Innovative Drugshttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-07T13:30:00-05:002024-03-07T13:30:00-05:00A listing of drugs pursuant to sub-section C.08.004.1(9) of the Food and Drug 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.Memorandum of Understanding between the Competition Bureau and Health Canada [2024-03-07]https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents/memorandum-of-understanding-between-competition-bureau-health-canada.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-07T10:00:00-05:002024-03-07T10:00:00-05:00Health Canada and the Competition Bureau wish to acknowledge their relationship and recognize that cooperation can contribute to improved delivery respective mandates as they relate to 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.Updated Register of Certificates of Supplementary Protection and Applicationshttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates.htmlHealth Canadahttps://www.canada.ca/en/health-canada.html2024-03-04T15:00:00-05:002024-03-04T15:00:00-05:00Listing of drugs pursuant to sub-section 120(1) of the Certificate of Supplementary Protection 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.