Biologics, radiopharmaceuticals and genetic therapies

Current consultations

• Consultation: Notice of intent to amend the regulations to address health product shortages in Canada [2024-06-25]
• Consultation on improving access to drugs and other health products in Canada [2023-06-05]
• Consultation: Exceptions to the Prescription Drug List [2022-07-28]
• Consultation Regarding Dear Health Care Professional Letters for Notice of Compliance with Conditions [2016-04-15]
• Draft - Revised Guidance Document: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) [2015-12-07]

Past consultations

• Consultation on the Draft Guidance Document: Harmonized requirements for the licensing of vaccines and guidelines for the preparation of an application [2015-06-03]
• Notice to stakeholders - Release of Guidance Document for consultation: Regulation of Fecal Microbiota Therapy for the Treatment of C. difficile Infections [2015-03-30]
• Consultation on the Release of draft Part I: Health Professional Information and Part II: Scientific Information - Guidance Document: Product Monograph [2014-12-19]
• Consultation on draft Guidance for Sponsors: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans [2014-10-07]
• Consultation on the draft guidance document: Annual update of seasonal influenza vaccines [2014-09-11]
• Notice to stakeholders - Release of draft Guidance document for consultation: A Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals Used in Basic Clinical Research Studies [2013-12-16]
• Public Consultation on the Safety of Paid Plasma Donations [2013-06-27]
• Notice to Stakeholders - Release of draft Guidance document for consultation: Submission and Information Requirements for Extraordinary Use New Drugs (EUNDS) [2013-02-12]
• Consultation on the new Prescription Drug List [2012-12-24]
• Notice to Stakeholders - Release of draft Guidance document for consultation: Submission Information for Human-Use Biologic Drugs Derived from Plant Molecular Farming (PMF) [2012-12-17]
• Consultation on Health Canada's Public Clinical Trials Database [2012-12-13]
• Notice - Draft 2^nd Edition "Guidance Document for Cell, Tissue and Organ Establishments: Safety of Human Cells, Tissues and Organs for Transplantation" for consultation [2012-10-02]
• Notice to Stakeholders - Release of the Draft Guidance Interpreting the Blood Regulations for stakeholder consultation [2012-05-28]
• Release of revised guidance document: considerations for inclusion of women in clinical trials and analysis of data by sex [2012-01-09]

Additional resources

• Advisory Committees