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Preparation of Drug Submissions - Guidance Documents - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies

• Notice - Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format [2013-04-18]
• Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format [2012-06-22]
• Notice - Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) electronic-only filing format [2011-09-30]
• Notice - Health Canada to stop sending Validation Reports for passed submissions [2011-09-09]
• Notice - Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) electronic-only filing format [2011-05-24]
• Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the eCTD Format Date: 2010-12-07
• Guidance Document: Schedule A and Section 3 to the Food and Drugs Act
  Date: 2010-10-26
• Notice - Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) Format and acceptance of electronic-only submissions 2010-08-20
• Notice - Submissions in Electronic Common Technical Document (eCTD) Format 2010-01-27
• Guidance for Industry: Preparation of Drug Submissions in the eCTD Format
  Date: 2009-11-04
  • Issue Analysis Summary Guidance for Industry: Preparation of Drug Submission in the eCTD Format
    Date: 2009-11-04
• Notice: Release of Health Canada's Revisions to"1.6 Electronic Review Documents" in Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format.
  Date: 2008-02-25
• Health Canada posts validation rules for submissions provided in the eCTD format
  Date: 2007-11-13
• Guidance for Industry: Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names
  Date: 2005-10-31
• Look-alike Sound-alike (LA/SA) Health Product Names: Comments and Responses to the Related Guidances.
  Date: 2005-07-25
• Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the eCTD Format
  Date: 2005-05-16
• Guidance for Sponsors: Regulatory Requirements for Intravenous Immunoglobulins Products in Canada
  Date: 2004-08-04
• Guidance for Clinical Trial Sponsors: Clinical Trial Applications
  Date: 2003-06-25
• The Common Technical Document- ICH Topic M4
  Date: 2003-06-25
• Preparation of Human New Drug Submissions Therapeutic Products Programme Guideline
  Date: 1991-07-17
• Guideline on Preparation of DIN Submissions
  Date: 1995-02-22
• Revision of the Product Monograph and Templates
  Date: 2003-10-01
• Guidance for Industry: Product Monograph
  Date: 2003-10-01
• Executive Summary - Health Canada Consumer Information Study Report to Health Canada
  Date: 2001-10-12