International Conference on Harmonization (ICH) Guidances
Quality | Safety | Efficacy | Multidisciplinary
A complete list of ICH Guidances can be found at ICH Guidelines.
Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.
Quality
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 79 KB) - 01/9/2009
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter (PDF - 1.18 MB) - 1/9/2009
International Conference on Harmonisation (ICH);
Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF)
- 8/7/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF) - 8/7/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF) - 8/7/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 5: Disintegration Test General Chapter (PDF) - 8/7/2008
International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances - 6/5/2008
International Conference on Harmonisation (ICH); Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - 2/21/2008
International Conference on Harmonisation (ICH); Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 1
Residue on Ignition/Sulphated Ash General Chapter - 2/21/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q8(R1) Pharmaceutical Development Revision 1 - 1/10/2008
International Conference on Harmonisation (ICH); Draft Guidance: Q10 Pharmaceutical Quality System - 7/12/2007
International Conference on Harmonisation (ICH); Guidance for Industry: Q3B(R2) Impurities in New Drug Products - 7/31/2006
International Conference on Harmonisation (ICH): Q2(R1) Validation of Analytical Procedures: Text and Methodology
Note: In November 2005, the ICH incorporated Q2B on methodology with the parent guidance Q2A and retitled the combined Q2 document. The contents of the two guidances were not revised.
International Conference on Harmonisation (ICH); Guidance for Industry: Q9 Quality Risk Management - 6/1/2006
International Conference on Harmonisation (ICH); Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process - 6/29/2005
International Conference on Harmonisation (ICH); Guidance for Industry: Q1E Evaluation of Stability Data - 6/7/2004
International Conference on Harmonisation (ICH); Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products - 11/20/2003
International Conference on Harmonisation (ICH); Guidance for Industry: Q3C - Tables and List - 11/12/2003
International Conference on Harmonisation (ICH); Guidance for Industry; Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products - 1/15/2003
IInternational Conference on Harmonisation (ICH); Guidance for Industry: Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - 9/25/2001
International Conference on Harmonisation (ICH): Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances - 12/29/2000 -(PDF),
(Text)
International Conference on Harmonisation (ICH): Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products - 8/18/1999 -
(PDF),
(Text)
International Conference on Harmonisation (ICH): Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin - 9/24/1998 -
(PDF),
(Text)
International Conference on Harmonisation (ICH): Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products - 9/21/1998 -
(PDF),
(Text)
International Conference on Harmonisation (ICH) Guidelines for the Photostability Testing of New Drug Substances and Products - 5/16/1997 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); Guidance for Industry: Q1C Stability Testing for New Dosage Forms (PDF) - 11/1996
International Conference on Harmonisation: Final Guidance on Stability Testing of Biotechnological / Biological Products - 7/10/1996 -
(PDF),
(Text)
International Conference on Harmonisation (ICH): Final Guideline on Quality of Biotechnical Products: Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products - 2/1996
Safety
International Conference on Harmonisation: (ICH); Guidance for Industry: S1C(R2) Dose Selection for Carcinogenicity Studies (PDF - 185 KB) - 9/17/2008
International Conference on Harmonisation (ICH); Draft Guidance: S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use - 3/25/2008
International Conference on Harmonisation (ICH); Guidance for Industry: S8 Immunotoxicity Studies for Human Pharmaceuticals - 4/12/2006
International Conference on Harmonisation (ICH); Guidance for Industry: S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
- 10/19/2005
International Conference on Harmonisation (ICH); Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals - 7/12/2001
International Conference on Harmonisation (ICH): S4A Duration of Chronic Toxicity Testing in Animals
(Rodent and Nonrodent Toxicity Testing) - 6/25/1999 -
(PDF),
(Text)
International Conference on Harmonisation: (ICH); Guidance for Industry: S1B Testing for Carcinogenicity of Pharmaceuticals (PDF) - 7/1997
I
International Conference on Harmonisation: (ICH); Guidance for Industry: S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF) - 7/1997
International Conference on Harmonisation (ICH); Guideline for Industry: S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility (PDF) - 4/1996
International Conference on Harmonisation (ICH): Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceutical - 3/1996
International Conference on Harmonisation: (ICH); Guideline for Industry: S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals (PDF) - 3/1995
International Conference on Harmonisation: (ICH); Guideline for Industry: S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF) - 3/1995
International Conference on Harmonisation: (ICH); Guideline for Industry: S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (PDF) - 3/1995
International Conference on Harmonisation (ICH); Guideline for Industry: S5A Detection of Toxicity to Reproduction for Medicinal Products (PDF) - 9/1994
Efficacy
International Conference on Harmonisation (ICH); Draft Guideline: E2F Development Safety Update Report (PDF) - 8/5/2008
International Conference on Harmonisation (ICH); Guidance for Industry: E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories - 4/7/2008
International Conference on Harmonisation (ICH); Guidance for Industry: E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data - Questions and Answers - 9/28/2006
International Conference on Harmonisation (ICH); Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
- 10/19/2005
International Conference on Harmonisation (ICH); Guidance for Industry: E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports - 9/30/2005
International Conference on Harmonisation (ICH); Guidance for Industry: E2E Pharmacovigilance
Planning - 3/31/2005
International Conference on Harmonisation (ICH); Guidance for Industry: E2B(M): Data Elements for Transmission of Individual Case Safety Reports: Questions and Answers (Revision 2) - 3/9/2005
International Conference on Harmonisation (ICH); Guidance for Industry: Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs - 2/4/2004
International Conference on Harmonisation (ICH); ICH E3 - Guideline for Industry: Structure and Content of Clinical Study Reports (PDF - 466 KB) - 7/1996
International Conference on Harmonisation (ICH); Draft Guidance for Industry: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting - 9/12/2003
International Conference on Harmonisation (ICH); Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials - 5/11/2001
International Conference on Harmonisation: (ICH); Draft Guidance: E12A Principles for Clinical Evaluation of New Antihypertensive Drugs - 8/2000
International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population - 12/15/2000
International Conference on Harmonisation (ICH): E9 Statistical Principles for Clinical Trials -
9/16/1998 -
(PDF),
(Text)
International Conference on Harmonisation (ICH): E5 Ethnic Factors in the Acceptability of Foreign Clinical Data -
6/10/1998 -
(PDF),
(Text)
International Conference on Harmonisation (ICH); E2B Guidance on Data Elements for Transmission of Individual Case Safety Reports (PDF) 1/15/1998
International Conference on Harmonisation: (ICH); Guidance: E8 General Considerations for Clinical Trials (PDF) - 12/1997
International Conference on Harmonisation (ICH); Guideline for Industry: E4 Dose-Response Information to Support Drug Registration (PDF) - 7/1996
International Conference on Harmonisation (ICH); Guidance for Industry: E6 Good Clinical Practice: Consolidated Guideline (PDF) - 4/1996
International Conference on Harmonisation: (ICH); Guideline for Industry: E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (PDF) - 3/1995
International Conference on Harmonisation: (ICH); Guideline for Industry: E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF) - 3/1995
International Conference on Harmonisation (ICH); Guideline for Industry: E7 Studies in Support of Special Populations: Geriatrics (PDF) - 8/1994
Multidisciplinary
International Conference on Harmonisation (ICH); Draft Guidance: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials andMarketing Authorization for Pharmaceuticals - 9/4/2008
International Conference on Harmonisation (ICH); Guidance for Industry: Granularity Document Annex to M4: Organization of the CTD - 10/18/2005
International Conference on Harmonisation (ICH); Draft Guideline: M5 Data Elements and Standards for Drug Dictionaries - 9/2/2005
International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions & Answers and Change Requests - 3/11/2005
International Conference on Harmonisation (ICH); Guidance for Industry: M-4: CTD -- Efficacy: Questions and Answers (Revision 3) - 12/22/2004
Clarification for Q&A 10 on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- General: Questions and Answers (Revision 3) - 12/22/2004
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Quality: Questions and Answers/Location Issues - 6/8/2004
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD -- Safety: Questions and Answers - 2/3/2003
International Conference on Harmonisation (ICH); Guidance on M4 Common Technical Document - 10/16/2001 -
Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format - General Considerations - 9/5/2001
International Conference on Harmonsation (ICH); M4 Common Technical Document: Modules IIA, IIB Nonclinical; Module III, Quality; Modules IV, Nonclinical; Module V, Efficacy - 2/10/2000
International Conference on Harmonisation (ICH); Guidance for Industry: M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (PDF) - 7/1997
