International Conference on Harmonisation - Efficacy
|
E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (PDF - 17KB)
|
Final Guidance
|
03/01/95
|
International Conference on Harmonisation - Efficacy
|
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF - 49KB)
|
Final Guidance
|
03/01/95
|
International Conference on Harmonisation - Efficacy
|
E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports (PDF - 70KB)
|
Final Guidance
|
01/15/98
|
International Conference on Harmonisation - Efficacy
|
E2BM Data Elements for Transmission Of Individual Case Safety Reports (PDF - 74KB)
|
Final Guidance
|
04/04/02
|
International Conference on Harmonisation - Efficacy
|
E2B(M) Questions and Answers (PDF - 55KB)
|
Final Guidance
|
03/09/05
|
International Conference on Harmonisation - Efficacy
|
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
|
Draft Guidance
|
10/19/11
|
International Conference on Harmonisation - Efficacy
|
E2C 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. (PDF - 169KB)
|
Final Guidance
|
05/19/97
|
International Conference on Harmonisation - Efficacy
|
E2C Addendum to ICH E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (PDF - 35KB)
|
Final Guidance
|
02/05/04
|
ICH - Efficacy
|
E2C(R2) Periodic Benefit-Risk Evaluation Report (PDF - 686KB)
|
Draft Guidance
|
04/10/12
|
International Conference on Harmonisation - Efficacy
|
E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting (PDF - 184KB)
|
Draft Guidance
|
09/12/03
|
International Conference on Harmonisation - Efficacy
|
E2E Pharmacovigilance Planning (PDF - 73KB)
|
Final Guidance
|
03/31/05
|
International Conference on Harmonisation - Efficacy
|
E2F Development Safety Update Report (PDF - 272KB)
|
Final Guidance
|
08/22/11
|
International Conference on Harmonisation - Efficacy
|
E3 Structure and Content of Clinical Study Reports (PDF - 240KB)
|
Final Guidance
|
07/01/96
|
International Conference on Harmonisation - Efficacy
|
E4 Dose-Response Information to Support Drug Registration (PDF - 49KB)
|
Final Guidance
|
07/01/96
|
International Conference on Harmonisation - Efficacy
|
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 89KB)
|
Final Guidance
|
06/01/04
|
Internation Conference on Harmonisation - Efficacy
|
E6 Good Clinical Practice: Consolidated Guideline (PDF - 262KB)
|
Final Guidance
|
04/01/96
|
International Conference on Harmonisation - Efficacy
|
E6 Good Clinical Practice: Consolidated Guideline (Spanish Language) (PDF - 178KB)
|
Final Guidance
|
04/01/96
|
International Conference on Harmonisation - Efficacy
|
E7 Studies in Support of Special Populations: Geriatrics (PDF - 25KB)
|
Final Guidance
|
08/01/94
|
International Conference on Harmonisation - Efficacy
|
E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers (PDF - 85KB)
|
Final Guidance
|
02/17/12
|
International Conference on Harmonisation - Efficacy
|
E8 General Considerations for Clinical Trials (PDF - 67KB)
|
Final Guidance
|
12/01/97
|
International Conference on Harmonisation - Efficacy
|
E9 Statistical Principles for Clinical Trials (PDF - 110KB)
|
Final Guidance
|
09/01/98
|
International Conference on Harmonisation - Efficacy
|
E10 Choice of Control Group and Related Issues in Clinical Trials (PDF - 93KB)
|
Final Guidance
|
05/01/01
|
International Conference on Harmonisation - Efficacy
|
E11 Clinical Investigation of Medicinal Products in the Pediatric Population (PDF - 60KB)
|
Final Guidance
|
12/01/00
|
International Conference on Harmonisation - Efficacy
|
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs (PDF - 27KB)
|
Draft Guidance
|
08/01/00
|
International Conference on Harmonisation - Efficacy
|
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (PDF - 67KB)
|
Final Guidance
|
10/19/05
|
International Conference on Harmonisation - Efficacy
|
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (PDF - 108KB)
|
Final Guidance
|
11/18/08
|
International Conference on Harmonisation - Efficacy
|
E15 Pharmacogenomics Definitions and Sample Coding (PDF - 90KB)
|
Final Guidance
|
04/07/08
|
International Conference on Harmonisation - Efficacy
|
E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions (PDF - 111KB)
|
Final Guidance
|
08/10/11
|