Efficacy

Some of the hyperlinks provided are to sites of organizations or other entities that are not subject to the Official Languages Act. The material found there is therefore in the language(s) used by the sites in question.

Should you have any questions or comments regarding the content of the guidance documents found on this page please contact:
Health Canada – ICH Coordinator
Email: HPFB_ICH_DGPSA@hc-sc.gc.ca

E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions [1995-06-01]
E2A: Clinical Safety Data Management Definitions and Standards for Expedited Reporting [1995-06-01]
- E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting - Reminder for Sponsors [2012-08-21]
E2C(R2) Guidance Document - Periodic Benefit-Risk Evaluation Report (PBRER) [2013-09-17]
- E2C(R2): Periodic Benefit Risk Evaluation Report (PBRER) - Notice [2013-04-09]
- E2C(R2): Periodic Benefit Risk Evaluation Report (PBRER) - Questions and Answers [2013-04-09]
E2D: Guidance Document - Reporting Adverse Reactions to Marketed Health Products [2018-10-18]
E2E: Pharmacovigilance Planning [2009-02-16]
E2F: Development Safety Update Report (DSUR) [2015-12-04]
- Check list for Submitting Requested Development Safety Update Reports (DSUR) in Electronic Format (PDF fillable/saveable (179 KB)) [2015-12-29]
E3: Structure and Content of Clinical Study Reports [1997-05-20]
- E3 Q&A(R1): Structure and Content of Clinical Study Reports Questions & Answers [2015-12-18]
E4: Dose Response Information to Support Drug Registration [1994-10-01]
E5(R1): Ethnic Factors in the Acceptability of foreign Clinical Data [2015-12-18]
- E5 Q&A(R1): Ethnic Factors in the Acceptability of foreign Clinical Data5(R1) [2016-01-04]
E6(R2): Good Clinical Practice [2019-04-03]
E7: Studies in Support of Geriatric Populations: Geriatrics [1994-10-01]
- E7 Q&A: Studies in Support of Special Populations: Geriatrics, Questions & Answers [2015-06-16]
E8(R1): General Considerations for Clinical Trials [2022-01-14]
E9: Statistical Principles of Clinical Trials [2003-02-10]
- E9(R1): Defining the Appropriate Estimand for a Clinical Trial/ Sensitivity Analyses [2020-07-21]
E10: Choice of Control Groups and Related Issues in Clinical Trials [2011-06-02]
E11: Clinical Investigation of Medicinal Products in the Pediatric Population [2003-12-17]
- E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population [2018-04-05]
E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs [2006-04-05]
- E14 Questions and Answers (R3): The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs [2016-06-10]
- Health Canada Question and Answer Document Regarding ICH S7B and E14 Guidances [2006-11-30]
- QT/QTc Interval Prolongation
E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories [2008-07-29]
E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions [2016-01-08]
E17: Multi-Regional Clinical Trials [2019-04-01]
E18: Genomic Sampling and Management of Genomic Data [2018-04-26]

Cross-cutting Topics

M9: Biopharmaceutics Classification System-based Biowaivers [2020-08-26]
- M9 Q&A: Biopharmaceutics Classification System-based Biowaivers [2020-08-26]

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Date modified:: 2022-03-24

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Efficacy

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