Drugs

International Council for Harmonisation - Efficacy

Below is a sortable list of the International Council For Harmonisation - Efficacy Guidance Documents. You can sort alphabetically by: Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

International Conference on Harmonisation has changed it's name to: International Council for Harmonisation

International Council of Harmonisation -Efficacy

CategoryTitleTypeDate
International Council for 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 Council for Harmonisation - Efficacy E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF - 49KB) Final Guidance 03/01/95
International Council 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 Council on Harmonisation - Efficacy E2BM Data Elements for Transmission Of Individual Case Safety Reports (PDF - 162KB) Final Guidance 04/04/02
International Council on Harmonisation - Efficacy E2B(M) Questions and Answers (PDF - 61KB) Final Guidance 03/09/05
International Council 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 Final Guidance 02/21/14
International Council on Harmonisation- Efficacy E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) (PDF - 462KB) Final Guidance 07/18/16
International Council on Harmonisation - Efficacy E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting (PDF - 165KB) Draft Guidance 09/12/03
International Council on Harmonisation - Efficacy E2E Pharmacovigilance Planning (PDF - 100KB) Final Guidance 03/31/05
International Council on Harmonisation - Efficacy E2F Development Safety Update Report (PDF - 272KB) Final Guidance 08/22/11
International Council on Harmonisation - Efficacy E3 Structure and Content of Clinical Study Reports (PDF - 240KB) Final Guidance 07/01/96
International Council on Harmonisation - Efficacy E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1) (PDF - 141KB) Final Guidance 01/25/13
International Council on Harmonisation - Efficacy E4 Dose-Response Information to Support Drug Registration (PDF - 49KB) Final Guidance 07/01/96
International Council on Harmonisation - Efficacy E5 Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 79KB) Final Guidance 06/01/04
Internation Council on Harmonisation - Efficacy E6 Good Clinical Practice: Consolidated Guideline (PDF - 262KB) Final Guidance 04/01/96
International Council on Harmonisation - Efficacy E6 Good Clinical Practice: Consolidated Guideline (Spanish Language) (PDF - 178KB) Final Guidance 04/01/96
International Council on Harmonisation - Efficacy E7 Studies in Support of Special Populations: Geriatrics (PDF - 25KB) Final Guidance 08/01/94
International Council on Harmonisation - Efficacy E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers (PDF - 85KB) Final Guidance 02/17/12
International Council on Harmonisation - Efficacy E8 General Considerations for Clinical Trials (PDF - 67KB) Final Guidance 12/01/97
International Council on Harmonisation - Efficacy E9 Statistical Principles for Clinical Trials (PDF - 110KB) Final Guidance 09/01/98
International Council on Harmonisation - Efficacy E10 Choice of Control Group and Related Issues in Clinical Trials (PDF - 93KB) Final Guidance 05/01/01
International Council on Harmonisation - Efficacy E11 Clinical Investigation of Medicinal Products in the Pediatric Population (PDF - 60KB) Final Guidance 12/01/00
International Council on Harmonisation - Efficacy E12A Principles for Clinical Evaluation of New Antihypertensive Drugs (PDF - 27KB) Draft Guidance 08/01/00
International Council on Harmonisation - Efficacy E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (PDF - 98KB) Final Guidance 10/19/05
International Council on Harmonisation - Efficacy E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs - Questions and Answers (R1) Final Guidance 10/12/12
International Council on Harmonisation - Efficacy E15 Pharmacogenomics Definitions and Sample Coding (PDF - 53KB) Final Guidance 04/07/08
International Council 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
International Council on Harmonisation - Efficacy E6(R2) Good Clinical Practice (PDF - 363KB) Draft Guidance 09/28/15
ICH - Efficacy E18 Genomic Sampling and Management of Genomic Data (PDF - 171KB) Draft Guidance 06/02/16
International Conference on Harmonization - Efficacy E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers (PDF - 153KB) Final Guidance 07/18/16

Page Last Updated: 08/16/2016
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