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Biologics, Radiopharmaceuticals and Genetic Therapies
Current Consultations
Notice to Stakeholders - Release of draft Guidance document for consultation: Submission and Information Requirements for Extraordinary Use New Drugs (EUNDS)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Notice to Stakeholders - Release of draft Guidance document for consultation: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]
Past Consultations
Notice to Stakeholders -- Release of the Draft Guidance Interpreting the Blood Regulations for stakeholder consultation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]
Consultation on proposed Phase II of the Summary Basis of Decision Project
[2011-10-19]
Release of Draft Guidance Document: Regulatory Framework for Allergenic Substances of Biological Origin used for the Diagnosis or Treatment of Allergic Diseases
[2011-09-15]
Draft Guidance Document - Product Monograph - Part III: Consumer Information
[2011-07-21]
Notice - Good Laboratory Practice (GLP) Recognition for Canadian Facilities: Reminder to schedule your inspection before the end of the transition period
[2010-09-30]
Additional Resources
Advisory Committees