Guidance documents - Biologics, Radiopharmaceuticals and Genetic Therapies

The following guidance documents have been prepared to assist in the interpretation of the policies governing statutes and regulations.

• Notice to Stakeholders - Consultation on the Revised Guidance for Industry Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products
• Overview of the Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals
• Filing Submissions Electronically
• Health Canada Policy Position Paper – Autologous Cell Therapy Products
• Guidance for Sponsors: Regulatory Requirements for Intravenous Immunoglobulin (IVIG) Products in Canada [2018-12-20]
• Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format [2012-06-22]
• Guidance for Industry Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotechnological/ Biological (Biotech) Products [2018-07-09]
• Guidance for Industry, Preparation of the Quality Information for Drug Submissions in the CTD Format: Blood Products [2004-05-25]
• Guidance for Industry, Preparation of the Quality Information for Drug Submissions in the CTD Format: Conventional Biotherapeutic Products [2004-05-25]
• Guidance Document Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an Application [2018-03-12]
• Publication of the Final Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs [2019-06-28]
• Notice - Prescription Drug List (PDL): Multiple Additions [2017-10-19]
• Updates to the Prescription Drug List [2017-10-19]
• Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs [2005-06-01]
• Notice: Release of the Final Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements [2017-04-28]
• Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs [2017-05-11]
• Prescription Drug List [2017-04-21]
• Guidance Document: Interim Compliance Approach Regarding the Testing of Semen Donors for Treponema pallidum (Syphilis) [2016-11-01]
• Notice - Prescription Drug List (PDL): Multiple Additions [2015-10-16]
• Amendments to the Food and Drugs Act Guide to New Authorities
• Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities - What We Heard
• Allergenic products of biological origin
• Blood Regulations
  • Overview
  • Guidance Document: Blood Regulations (modified March 8, 2016)
• Clinical Trials
• Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences
• Cost Recovery
• Management of Drug Submissions [in effect until March 31, 2020]
• Management of Drug Submissions and Applications (formerly Management of Drug Submissions) [2021-05-26]
• Drug Submission Status Requests
  • Drug Submission Status Requests: Biologics and Genetic Therapies Directorate
  • Drug Submission Status Requests: Therapeutic Products Directorate
• Drugs Currently Regulated as New Drugs
• Fecal Microbiota Therapy
  • Guidance Document: Fecal Microbiota Therapy Used in the Treatment of Clostridium difficile Infection Not Responsive to Conventional Therapies [2016-08-xx]
  • Appendix 1: Notification of Fecal Microbiota Therapy Used in the Treatment of C. difficile Infection Not Responsive to Conventional Therapies Form (PDF Version - 354 KB)
• Good Guidance Practices
• Good Manufacturing Practices
• Guidance Document: Preparation of Clinical Trial Applications for Use of Cell Therapy Products in Humans
• Guidance Document: Schedule A and Section 3 to the Food and Drugs Act
• ICH
• Influenza - Guidance document: Annual update of seasonal influenza vaccines [2015-01-30]
• Notice of Compliance with Conditions
• Official Methods
• Patented Medicines
• Plant Molecular Farming
  • Guidance Document - Plant Molecular Farming (PMF) Applications: Plant-Derived Biologic Drugs for Human Use
  • General Questions and Answers on Plant Molecular Farming (PMF)
• Policy Statement: Clarifying the appropriate regulatory pathway for subsequent entry low molecular weight heparins
• Post-Notice of Compliance (NOC) Changes
• Prescription Drug List [2015-08-12]
  • Guidance Document: Determining Prescription Status for Human and Veterinary Drugs [2013-06-21]
  • Questions and Answers - Prescription Drug List [2013-12-20]
  • Consultation on the new Prescription Drug List [2012-12-24]
• Priority Review
• QT/QTc Interval Prolongation
• Radiopharmaceuticals
  • Radiopharmaceuticals, Kits, and Generators: Submission Information for Schedule C Drugs - Guidance document [2019-08-13]
  • Guidance document - Use of Positron-emitting Radiopharmaceuticals in Basic Clinical Research [2019-07-18]
  • Regulatory roadmap for radiopharmaceutical (Schedule C) drugs in Canada
  • Guidance Document: Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) [2020-04-01]
  • Annex to the Good Manufacturing Practices Guidelines - Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs) [2006-02-02]
  • Draft Guidance for Industry, Preparation of the Quality Information for Radiopharmaceuticals (Schedule C Drugs) using the Quality Information Summary-Radiopharmaceuticals (QIS-R) and Certified Product Information Document- Radiopharmceuticals (CPID-R) Templates [2001-08-01]
• Reconsideration of Final Decisions
• Release of the finalized Guidance Document: Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice [2010-04-30]
• Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs)