Clinical Trials

COVID-19

• Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors [2020-03-23]
• Applications for COVID-19 drug and medical device clinical trials under the Interim Order: Notice release of guidance documents [2020-05-27]
• Applications for medical device clinical trials under the Interim Order: Guidance document [2020-05-27]
• Applications for drug clinical trials under the Interim Order: Guidance document [2020-05-27]
• Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2020-05-27]

Clinical trials guidance

• Quality requirements for investigational biologic drugs used in clinical trials: Notice to clinical trial sponsors [2024-02-09]
• A guide to the new disaggregated data questionnaire for drug submissions [2022-10-03]
• Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications [2021-03-31]
• Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations when Conducting Clinical Research with Cannabis [2020-09-18]
• Order to extend review period for clinical trial applications and amendments: Notice [2020-08-14]
• Instructions for Completing the Clinical Trial Site Information Form  [2019-11-29]
• Notice to Stakeholders: Statement on the Investigational Use of Marketed Drugs in Clinical Trials [2019-06-05]
• Guidance for Clinical Trial Sponsors: Clinical Trial Applications [2016-03-18]
• Notice: Preparation of Clinical Trial Regulatory Activities in the "Non-eCTD Electronic-Only" Format [2016-03-02]
• Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans [2015-08-21]
• Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals [2009-03-12]
  • Quality Overall Summary - Chemical Entities (Clinical Trial Applications Phase I) (QOS-CE (CTA - Phase I)) [2008-11-12]
  • Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Phase II) (QOS-CE (CTA - Phase II)) [2008-11-12]
  • Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Phase III) (QOS-CE (CTA - Phase III)) [2008-11-12]
• Notice: Update for Clinical Trial Sponsors: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties [2007-12-18]
• Standards for Clinical Trials in Type 2 Diabetes in Canada [2007-09-24]
• Clinical Trials Manual
• ICH Guidances
• Guidance for Clinical Trial Sponsors: Clinical Trial Applications [2013-06-21]
• The Common Technical Document - ICH Topic M4 [2003-06-25]
• Inclusion of Women in Clinical Trials [1997-05-27]