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Drugs

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International Conference on Harmonisation - Efficacy

 Title and Format  Type  Issue Date
E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (PDF - 17 KB) Final 3/1995
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF - 49 KB) Final

3/1995

 
E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports  (PDF - 69 KB) Final 1/15/1998
E2B(R) Clinical Safety Data Management:  Data Elements for Transmission of Individual Case Safety Reports   (Issued , Posted 9/30/2005) Draft 9/30/2005

E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs 

Note: In November 2005, the ICH incorporated the E2C addendum with the E2C parent guidance and retitled the combined document E2C(R1). The contents of the two guidances were not revised.

 

 

 

 

Final

Final

 

 

 

 

 

5/19/1997

2/5/2004

 
E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting Draft 9/12/2003
E2E Pharmacovigilance Planning Final 3/31/05

E2F Development Safety Update Report  

 Draft 8/4/2008
E3 Structure and Content of Clinical Study Reports  Final 7/1996
E4 Dose-Response Information to Support Drug Registration  Final 7/1996
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data Final  6/2004
E6 Good Clinical Practice: Consolidated Guideline
Spanish Version [PDF] 		Final 5/9/1997
E7 Studies in Support of Special Populations: Geriatrics  Final 8/1994

E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers

 

 Draft 11/9/2009
E8 General Considerations for Clinical Trials  Final 12/1997
E9 Statistical Principles for Clinical Trials Final 9/1/1998
E10 Choice of Control Group and Related Issues in Clinical Trials Final 5/2001
E11 Clinical Investigation of Medicinal Products in the Pediatric Population Final 12/2000
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs.  Draft 8/2000

E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

Questions and Answers 
Final

10/19/2005

11/18/2008
E15 Pharmacogenomics Definitions and Sample Coding
Final

 4/7/2008

E16 Genomic Biomarkers Related to Drug Response:Context, 
Structure, and Format of Qualification Submissions

 

 Draft 7/30/2009
    
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