Preparation of Drug Submissions - Guidance Documents - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies
- Notice: Validation rules for regulatory transactions provided to Health Canada in the “non-eCTD electronic-only” format [2017-07-28]
- Notice – Mandatory use of the Electronic Common Technical Document (eCTD) format [2017-04-24]
- Updated - Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format [2016-12-14]
- Notice - Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format [2016-12-01]
- Guidance Document: Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an Application [2016-07-05]
- Common Electronic Submissions Gateway [2014-01-31]
- Guidance Document: Schedule A and Section 3 to the Food and Drugs Act [2010-10-26]
- Look-alike Sound-alike (LA/SA) Health Product Names: Comments and Responses to the Related Guidances. [2005-07-25]
- Guidance for Sponsors: Regulatory Requirements for Intravenous Immunoglobulins Products in Canada [2018-12-21]
- Guidance for Clinical Trial Sponsors: Clinical Trial Applications [2003-06-25]
- The Common Technical Document- ICH Topic M4 [2003-06-25]
- Guideline on Preparation of DIN Submissions [1995-02-22]
- Revision of the Product Monograph and Templates [2003-10-01]