ICH GUIDELINES

QUALITY
ICH ICH Guideline Title Step No Date
Guideline
Q1A(R2) Stability Testing of New Drug Step 5 6 February 2003
Substances and Products Date of Step 4

Q1B Stability Testing : Photostability Testing Step 5 6 November

of New Drug Substances and Products 1996
Date of Step 4

Q1C Stability Testing for New Dosage Forms Step 5 6 November

1996
Date of Step 4

Q1D Bracketing and Matrixing Designs for Step 5 7 February 2002

Stability Testing of New Drug Date of Step 4
Substances and Products
Q1E Evaluation of Stability Data Step 5 6 February 2003
Date of Step 4

Q1F Stability Data Package for Registration Withdrawn -

Applications in Climatic Zones III and
IV
Q1/Q5C Targeted Revisions of the ICH Stability - -
EWG Guideline Series
Q2(R1) Validation of Analytical Procedures: Step 5 1 November
Text and Methodology 2005
Date of Step 4

Q2(R2)/ Analytical Procedure Development and Step 3 24 March 2022

Q14 EWG - Revision of Q2 (R1) Analytical Date of Step 2b
Validation
Q3A(R2) Impurities in New Drug Substances Step 5 25 October 2006
Date of Step 4
Q3B(R2) Impurities in New Drug Products Step 5 2 June 2006
Date of Step 4

Q3C(R7) Maintenance of the Guideline for Withdrawn -

Residual Solvents
Q3C(R8) Guideline for Residual Solvents Step 5 22 April 2021
Date of Step 4
Q3C(R9) Maintenance of the Guideline for Step 1 -
Residual Solvents
Q3D Guideline for Elemental Impurities Step 5 12 November
2014
Date of Step 4
 Q3D Implementation of Guideline for - -
training Elemental Impurities
Q3D(R2) Guideline for Elemental Impurities Step 5 26 April 2022
Date of Step 4
Q3D(R3) Maintenance of the Guideline for Step 5 Step 4 on April
Elemental Impurities 2022
Q3E EWG Impurity: Assessment and Control of Step 1 -
Extractables and Leachables for
Pharmaceuticals and Biologics
Q4A Pharmacopoeial Harmonisation - -
Q4B - Evaluation and Recommendation of Step 5 1 November
Pharmacopoeial Texts for Use in the ICH 2007
Regions Date of Step 4
Q4B Annex Residue on Ignition/Sulphated Ash Step 5 27 September
1(R1) General Chapter 2010
Date of Step 4
Q4B Annex Test for Extractable Volume of Step 5 27 September
2(R1) Parenteral Preparations General Chapter 2010
Date of Step 4
Q4B Annex Test for Particulate Contamination: Sub- Step 5 27 September
3(R1) Visible Particles General Chapter 2010
Date of Step 4
Q4B Annex Microbiological Examination of Non- Step 5 27 September
4A(R1) Sterile Products: Microbial Enumeration 2010
Tests General Chapter Date of Step 4
Q4B Annex Microbiological Examination of Non- Step 5 27 September
4B(R1) Sterile Products: Tests for Specified 2010
Micro-Organisms General Chapter Date of Step 4
Q4B Annex Microbiological Examination of Non- Step 5 27 September
4C(R1) Sterile Products: Acceptance Criteria for 2010
Pharmaceutical Preparations and Date of Step 4
Substances for Pharmaceutical Use
General Chapter
Q4B Annex Disintegration Test General Chapter Step 5 27 September
5(R1) 2010
Date of Step 4
Q4B Annex Uniformity of Dosage Units General Step 5 13 November
6 Chapter 2013
Date of Step 4
Q4B Annex Dissolution Test General Chapter Step 5 11 November
7(R2) 2010
Date of Step 4
Q4B Annex Sterility Test General Chapter Step 5 27 September
8(R1) 2010
Date of Step 4
Q4B Annex Tablet Friability General Chapter Step 5 27 September
9(R1) 2010
Date of Step 4
Q4B Annex Polyacrylamide Gel Electrophoresis Step 5 27 September
10(R1) General Chapter 2010
Date of Step 4
Q4B Annex Capillary Electrophoresis General Step 5 9 June 2010
11 Chapter Date of Step 4
Q4B Annex Analytical Sieving General Chapter Step 5 9 June 2010
12 Date of Step 4
Q4B Annex Bulk Density and Tapped Density of Step 5 7 June 2012
13 Powders General Chapter Date of Step 4
Q4B Annex Bacterial Endotoxins Test General Step 5 18 October 2012
14 Chapter Date of Step 4
Q4B FAQs Frequently Asked Question - -
Q5A(R1) Viral Safety Evaluation of Biotechnology Step 5 23 September
Products Derived from Cell Lines of 1999
Human or Animal Origin Date of Step 4
Q5A(R2) Viral Safety Evaluation of Biotechnology Step 3 29 September
EWG - Products Derived from Cell Lines of 2022
Human or Animal Origin Date of Step 2
Q5B - Analysis of the Expression Construct in Step 5 30 November
Cells Used for Production of r-DNA 1995
Derived Protein Products Date of Step 4
Q5C Quality of Biotechnological Products: Step 5 30 November
Stability Testing of 1995
Biotechnological/Biological Products Date of Step 4
Q5D Derivation and Characterisation of Cell Step 5 16 July 1997
Substrates Used for Production of Date of Step 4
Biotechnological/Biological Products
Q5E Comparability of Step 5 18 November
Biotechnological/Biological Products 2004
Subject to Changes in their Date of Step 4
Manufacturing Process
Q6A Specifications : Test Procedures and Step 5 6 October 1999
Acceptance Criteria for New Drug Date of Step 4
Substances and New Drug Products:
Chemical Substances
Q6B Specifications : Test Procedures and Step 5 10 March 1999
Acceptance Criteria for Date of Step 4
Biotechnological/Biological Products
Q7 Good Manufacturing Practice Guide for Step 5 10 November
Active Pharmaceutical Ingredients 2000
Date of Step 4
Q7 Q&As Questions and Answers: Good Step 5 10 June 2015
Manufacturing Practice Guide for Active Date of Step 4
Pharmaceutical Ingredients
Q8(R2) - Pharmaceutical Development Step 5 1 August 2009
Date of Step 4
Q8/9/10 Q8/Q9/Q10 - Implementation Step 5 11 November
Q&As (R4) 2010
Date of Step 4
 Q9(R1) Quality Risk Management Step 5 18 January 2023
EWG Date of Step 4
Q10 Pharmaceutical Quality System Step 5 4 June 2008
Date of Step 4
Q11 Development and Manufacture of Drug Step 5 1 May 2012
Substances (Chemical Entities and Date of Step 4
Biotechnological/Biological Entities)
Q11 Q&As Questions & Answers: Selection and Step 5 23 August 2017
Justification of Starting Materials for the Date of Step 4
Manufacture of Drug Substances
Q12 Technical and Regulatory Considerations Step 5 20 November
for Pharmaceutical Product Lifecycle 2019
Management Date of Step 4
Q12 IWG Training on Regulatory and Technical Step 5 November 2019
Considerations for Pharmaceutical Date of Step 4
Product Lifecycle Management
Q13 Continuous Manufacturing of Drug Step 5 16 November
Substances and Drug Products 2022
Date of Step 4
Q13 IWG Training on Continuous Manufacturing - January 2023
of Drug Substances and Drug Products Step 4
Q2(R2)/ Analytical Procedure Development and Step 3 24 March 2022
Q14 EWG Revision of Q2 (R1) Analytical Date of Step 2b
Validation

STABILITY

ICH ICH Guideline Title Step No Date

Guideline
S1A Need for Carcinogenicity Studies of Step 5 29 November 1995
Pharmaceuticals Date of Step 4
S1B Testing for Carcinogenicity of Step 5 16 July 1997
Pharmaceuticals Date of Step 4
S1B(R1) Testing for Carcinogenicity of Step 5 4 August
EWG Pharmaceuticals 2022
Date of Step 4
S1C(R2)  Dose Selection for Carcinogenicity Step 5 11 March 2008
Studies of Pharmaceuticals Date of Step 4
S2(R1) Guidance on Genotoxicity Testing Step 5 9 November 2011
and Data Interpretation for Date of Step 4
Pharmaceuticals Intended for Human
Use
S3A  Note for Guidance on Step 5 27 October 1994
Toxicokinetics: The Assessment of Date of Step 4
Systemic Exposure in Toxicity
Studies
S3A Q&As Questions and Answers: Note for Step 5 16 November 2017
 Guidance on Toxicokinetics: The Date of Step 4
Assessment of Systemic Exposure -
Focus on Microsampling
S3B  Pharmacokinetics: Guidance for Step 5 27 October 1994
Repeated Dose Tissue Distribution Date of Step 4
Studies
S4 - Duration of Chronic Toxicity Step 5 2 September 1998
Testing in Animals (Rodent and Non Date of Step 4
Rodent Toxicity Testing)
S5(R2) Detection of Toxicity to Step 5 1 November 2005
Reproduction for Medicinal Products Date of Step 4
& Toxicity to Male Fertility
S5(R3) - Revision of S5 Guideline on Step 5 18 February 2020
Detection of Toxicity to Date of Step 4
Reproduction for Human
Pharmaceuticals
S5(R4) evision of S5 Guideline on Detection - March 2019
Maintenance of Toxicity to Reproduction for
EWG  Human Pharmaceuticals
S6(R1)  Preclinical Safety Evaluation of Step 5 12 June 2011
Biotechnology-Derived Date of Step 4
Pharmaceuticals
S7A - Safety Pharmacology Studies for Step 5 8 November 2000
Human Pharmaceuticals Date of Step 4
S7B  The Non-Clinical Evaluation Step 5 12 May 2005
of the Potential for Delayed Date of Step 4
Ventricular Repolarization (QT
Interval Prolongation) by Human
Pharmaceuticals
S8  Immunotoxicity Studies for Human Step 5 15 September 2005
Pharmaceuticals Date of Step 4
S9  Nonclinical Evaluation for Step 5 18 November 2009
Anticancer Pharmaceuticals Date of Step 4
S9 Q&As Questions and Answers: Step 5 27 April 2018
Nonclinical Evaluation for Date of Step 4
Anticancer Pharmaceuticals
S10  Photosafety Evaluation of Step 5 13 November 2013
Pharmaceuticals Date of Step 4
S11 Nonclinical Safety Testing in Step 5 14 April 2020
Support of Development of Date of Step 4
Paediatric Medicines
S12 EWG Nonclinical Biodistribution Step 3 3 June 2021
Considerations for Gene Therapy Date of Step 2
Products

EFFICACY
 ICH ICH Guidelines list Status Date
Guidelines
E1 The Extent of Population Exposure Step 5 27 October 1994
to Assess Clinical Safety for Drugs Date of Step 4
Intended for Long-Term Treatment
of Non-Life Threatening
Conditions
E2A Clinical Safety Data Management: Step 5 27 October 1994
Definitions and Standards for Date of Step 4
Expedited Reporting
E2B(R3) Clinical Safety Data Step 5 1 November 2012
Management: Data Elements for Date of Step 4
Transmission of Individual Case
Safety Reports (ICSRs)
E2B(R3) Clinical Safety Data Management: Step 5 17 January 2023
Q&As Data Elements for Transmission of Date of Step 4
Individual Case Safety Reports
E2B(R3) Electronic transmission of - -
EWG/IWG Individual Case study Reports
(ICSRs)
E2C(R2) Periodic Benefit-Risk Evaluation Step 5 17 December 2012
Report Date of Step 4

E2C(R2) Questions & Answers: Periodic Step 5 31 March 2014

Q&As Benefit-Risk Evaluation Report Date of Step 4

E2D Post-Approval Safety Data Step 5 12 November 2003

Management: Definitions and Date of Step 4
Standards for Expedited Reporting
E2D(R1) Post Approval Safety Data Step 1 This topic was
EWG Management: Definition and endorsed by the ICH
Standards for Expedited Reporting Assembly in June
2019.
E2E  Pharmacovigilance Planning Step 5 18 November 2004
Date of Step 4

E2F Development Safety Update Report Step 5 17 August 2010

Date of Step 4

E3 Structure and Content of Clinical Step 5 30 November 1995

Study Reports Date of Step 4

E3 Q&As Questions & Answers: Structure Step 5 6 July 2012

(R1) and Content of Clinical Study Date of Step 4
Reports
E4 Dose-Response Information to Step 5 10 March 1994
Support Drug Registration Date of Step 4

E5 Q&As Questions & Answers: Ethnic Step 5 2 June 2006

 (R1) Factors in the Acceptability of Date of Step 4
Foreign Clinical Data
E5(R1) Ethnic Factors in the Step 5 5 February 1998
Acceptability of Foreign Clinical Date of Step 4
Data
E6(R2) Good Clinical Practice (GCP) Step 5 10 November 2016

E6(R3) EWG Good Clinical Practice (GCP) Step 1 -

E7  Studies in Support of Special Step 5 24 June 1993
Populations: Geriatrics Date of Step 4
E7 Q&As  Questions & Answers: Studies in Step 5 16 July 2010
Support of Special Populations : Date of Step 4
Geriatrics
E8  General Considerations for Step 5 17 July 1997
Clinical Trials Date of Step 4
E8(R1)  General Considerations for Step 5 6 October 2021
Clinical Studies Date of Step 4
E9 Statistical Principles for Clinical Step 5 5 February 1998
Trials Date of Step 4
E9(R1) Addendum: Statistical Principles Step 5 20 November 2019
for Clinical Trials Date of Step 4
E10 Choice of Control Group and Step 5 20 July 2000
Related Issues in Clinical Trials Date of Step 4
E11(R1)  Addendum: Clinical Investigation Step 5 18 August 2017
of Medicinal Products in the Date of Step 4
Pediatric Population
E11A EWG  Paediatric Extrapolation Step 3 4 April 2022
Date of Step 2
E12 Principles for Clinical Evaluation - -
of New Antihypertensive Drugs
E14 The Clinical Evaluation of QT/QTc Step 5 12 May 2005
Interval Prolongation and Date of Step 4
Proarrhythmic Potential for Non-
Antiarrhythmic Drugs
E14 Q&As Questions & Answers: The Clinical Step 5 10 December 2015
(R3) Evaluation of QT/QTc Interval Date of Step 4
Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic
Drugs
E14/S7B Questions & Answers: Clinical and Step 5 21 February 2022
IWG Nonclinical Evaluation of QT/QTc Date of Step 4
Interval Prolongation and
Proarrhythmic Potential
E15 Definitions for Genomic Step 5 1 November 2007
Biomarkers, Pharmacogenomics, Date of Step 4
Pharmacogenetics, Genomic Data
and Sample Coding Categories
E16 Biomarkers Related to Drug or Step 5 20 August 2010
Biotechnology Product Date of Step 4
 Development: Context, Structure
and Format of Qualification
Submissions
E17 General principles for planning and Step 5 16 November 2017
design of Multi-Regional Clinical Date of Step 4
Trials
E18 Genomic Sampling and Step 5 6 September 2017
Management of Genomic Data Date of Step 4
E19 A Selective Approach to Safety Step 5 27 September 2022
Data Collection in Specific Late- Date of Step 4
Stage Pre-approval or Post-
Approval Clinical Trials
E20 EWG Adaptive Clinical Trials Step 1 -
E21 informal Inclusion of Pregnant and - May 2022
WG Breastfeeding Individuals in
clinical trials.

MULTIDISCIPLINARY

ICH ICH Guidelines List Step No Date

Guidelines
M1 - MedDR  Medical Dictionary for Regulatory Step 5 1 January 1999
A Activities
M1 PtC WG - MedDRA Points to Consider - -
M2 EWG  Electronic Standards for the - 27 October 1994
Transfer of Regulatory Information
M3(R2) Guidance on Nonclinical Safety Step 5 11 June 2009
Studies for the Conduct of Human
Clinical Trials and Marketing
Authorization for Pharmaceuticals
M3(R2) Q&As  Questions & Answers: Guidance on 15 June 2011
(R2) Nonclinical Safety Studies for the Step 5
Conduct of Human Clinical Trials
and Marketing Authorization for
Pharmaceuticals
M4 Q&As Questions & Answers: Organisation Step 5 10 June 2004
(R3)  of the Common Technical
Document for the Registration of
Pharmaceuticals for Human Use
M4(R4)  Organisation Including the Step 5 15 June 2016
Granularity document that provides
guidance on document location and
paginations
M4E Q&As Questions & Answers: CTD on Step 5 10 June 2004
(R4)  Efficacy
M5  Data Elements and Standards for - -
Drug Dictionaries
M6 Virus and Gene Therapy Vector - -
 Shedding and Transmission
M7  Assessment and Control of DNA Step 5 5 June 2014
Reactive (Mutagenic) Impurities in
Pharmaceuticals to Limit Potential
Carcinogenic Risk
M7(R1) Assessment and Control of DNA 1 June 2017
Reactive (Mutagenic) Impurities in
Pharmaceuticals to Limit Potential Step 5
Carcinogenic Risk
M7(R2) Assessment and Control of Step 5 6 October 2021
Maintenance DNA Reactive (Mutagenic)
EWG/IWG  Impurities in Pharmaceuticals to
Limit Potential Carcinogenic Risk
M7(R2) Assessment and Control of Step 3 29 June 2020
Q&As  DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals to
Limit Potential Carcinogenic Risk
M8 eCTD Electronic Common Step 5 1 July 2008
v3.2.2 Technical Document (eCTD) v3.2.2
M8 eCTD Electronic Common Technical Step 5 10 December 2015
v4.0  Document (eCTD) v4.0
M8 Electronic Common Technical Step 5 6 August 2018
EWG/IWG Document (eCTD)
M9  Biopharmaceutics Classification Step 5 20 November 2019
System-based Biowaivers
M9 Q&As &As on Biopharmaceutics Step 5 20 November 2019
Classification System-based
Biowaivers
MIDD DG  Model-Informed Drug Development - -
M10 EWG   Bioanalytical Method Validation Step 5 24 May 2022
and Study Sample Analysis
M10 Q&As Questions and Answers: Step 5
Bioanalytical Method Validation
and Study Sample Analysis 16 November 2022
M11 EWG Clinical electronic Structured Step 3 27 September 2022
Harmonised Protocol (CeSHarP)
M12 Drug Interaction Studies  Step 3 24 May 2022
EWG 
M13 EWG Bioequivalence for Immediate- Step 3 20 December 2022
Release Solid Oral Dosage Forms
M14 EWG General principles on plan, design, - -
and analysis of
pharmacoepidemiological studies
that utilize real-world data for safety
assessment of medicines