International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Find out about the collaborations with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Last updated 13 March 2026
Overview
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry, through scientific and technical discussions; to achieve greater harmonisation worldwide in ensuring that safe, effective, and high quality medicines are developed and registered efficiently. For more information on ICH, please refer to the ICH Official Website.
The Health Sciences Authority (HSA) has been an observer to the ICH platform since 2007. HSA was accepted as a Regulatory Member of the ICH in November 2017 (see press release) and was part of the ICH Management Committee (MC) from June 2018 to June 2021.
ICH Guidelines for Consultation
In accordance with the ICH process of Harmonisation, the Formal ICH Procedure is followed for the harmonisation of all new ICH topics. The procedure includes regulatory consultation to be conducted by ICH Members to seek stakeholder's feedback on the proposed draft guidelines or FAQs developed by the ICH EWGs/IWGs. Feedback received are forwarded to the relevant ICH EWGs/IWGs for consideration. The finalised guidelines are then endorsed at the ICH Assembly prior to publication on the ICH website.
Your feedback is important and contributes towards the finalisation of the ICH guidelines.
Please provide your comments using the template provided by ICH and email to HPRG_feedback@hsa.gov.sg with the subject title: ICH Feedback.
List of templates
Draft ICH Guidelines | Status for consultation | Deadline for comments |
Guideline Code: E20 | Open | 30 November 2025 |
Guideline Code: Q3E | Open | 30 November 2025 |
Guideline Code: M4Q(R2) | Open | 30 November 2025 |
Guideline Code: Q1 | Closed | 11 July 2025 |
Guideline Code: M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms | Closed | 15 June 2025 |
Adoption of ICH Guidelines by HSA
HSA aligns our regulatory approaches to the guidelines issued by the ICH, where applicable. These guidelines are assigned with topic codes based on the following categories:
Quality – covers areas such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
Safety – covers areas pertaining to potential risks like carcinogenicity, genotoxicity, reproductive and developmental toxicity.
Efficacy – covers areas relating to the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.
Multidisciplinary – These are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories.
Adopted ICH Guidelines
List of Adopted ICH Guidelines
ICH Guideline Topic Code | Document Title | Adoption Date (YYYY-MM) |
|---|---|---|
Q1A(R2) | Stability Testing of New Drug Substances and Products | Prior to 2008 |
Q1B | Stability Testing: Photostability Testing of New Drug Substances and Products | Prior to 2008 |
Q1C | Stability Testing for New Dosage Forms | Prior to 2008 |
Q1D | Bracketing and Matrixing Designs for Stability testing of New Drug Substances and Products | Prior to 2008 |
Q1E | Evaluation of Stability Data | Prior to 2008 |
Q2(R1) | Validation of Analytical Procedures: Text and Methodology | Prior to 2008 |
Q3A(R2) | Impurities in New Drug Substances | Prior to 2008 |
Q3B(R2) | Impurities in New Drug Products | Prior to 2008 |
Q3C(R8) | Guideline for Residual Solvents | 2021-09 |
Q3D(R2) | Guideline for Elemental Impurities | 2022-05 |
Q5A(R1) | Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin | Prior to 2008 |
Q5B | Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products | Prior to 2008 |
Q5C | Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products | Prior to 2008 |
Q5D | Derivation and Characterisation of Cell Substrates Used for the Production of Biotechnological/Biological Products | Prior to 2008 |
Q5E | Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process | Prior to 2008 |
Q6A | Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances | Prior to 2008 |
Q6B | Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products | Prior to 2008 |
Q7 | Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients | 2001-05 |
Q7 Q&As | Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients | 2015-06 |
Q8(R2) | Pharmaceutical Development | 2013-01 |
Q9 | Quality Risk Management | 2013-01 |
Q10 | Pharmaceutical Quality System | 2013-01 |
Q8/9/10 Q&As (R4) | Q8/Q9/Q10 Implementation | 2013-01 |
Q11 | Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) | 2013-01 |
Q11 | Q&As Selection and Justification of Starting Materials for the Manufacture of Drug Substances | 2021-01 |
S1A | Need for Carcinogenicity Studies of Pharmaceuticals | Prior to 2008 |
S1B | Testing for Carcinogenicity of Pharmaceuticals | Prior to 2008 |
S1C(R2) | Dose Selection for Carcinogenicity Studies of Pharmaceuticals | Prior to 2008 |
S2(R1) | Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use | 2011-11 |
S3A | Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies | 2011-11 |
S3A | Q&As Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure – Focus on Microsampling | 2017-11 |
S3B | Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies | 2011-11 |
S4 | Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) | 2011-11 |
S5(R3) | Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals | 2020-02 |
S6(R1) | Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals | 2011-11 |
S7A | Safety Pharmacology Studies for Human Pharmaceuticals | 2011-11 |
S7B | The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals | 2011-11 |
S8 | Immunotoxicity Studies for Human Pharmaceuticals | 2011-11 |
S9 | Nonclinical Evaluation for Anticancer Pharmaceuticals | 2011-11 |
S9 Q&As | Nonclinical Evaluation for Anticancer Pharmaceuticals | 2018-06 |
S10 | Photosafety Evaluation of Pharmaceuticals | 2013-11 |
S11 | Nonclinical Safety Testing in Support of Development of Paediatric Medicines | 2020-04 |
E1 | The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions | Prior to 2008 |
E2A | Clinical Safety Data Management: Definitions and Standards for Expedited Reporting | Prior to 2008 |
E2C(R2) | Periodic Benefit-Risk Evaluation Report | 2014-01 |
E2C(R2) Q&As | Periodic Benefit Risk Evaluation Report | 2014-01 |
E2D | Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting | Prior to 2008 |
E2E | Pharmacovigilance Planning | Prior to 2008 |
E2F | Development Safety Update Report | 2017-11 |
E3 | Structure and Content of Clinical Study Reports | Prior to 2008 |
E3 Q&As (R1) | Structure and Content of Clinical Study Reports | Prior to 2008 |
E4 | Dose-Response Information to Support Drug Registration | Prior to 2008 |
E5(R1) | Ethnic Factors in the Acceptability of Foreign Clinical Data | Prior to 2008 |
E5 Q&As (R1) | Ethnic Factors in the Acceptability of Foreign Clinical Data | Prior to 2008 |
E6(R2) | Good Clinical Practice (GCP) | Prior to 2008 |
E7 | Studies in Support of Special Populations: Geriatrics | Prior to 2008 |
E7 Q&As | Studies in Support of Special Populations: Geriatrics | Prior to 2008 |
E8(R1) | Revision on General Considerations for Clinical Studies | 2021-10 |
E9 | Statistical Principles for Clinical Trials | Prior to 2008 |
E9(R1) | Addendum: Statistical Principles for Clinical Trials | 2019-11 |
E10 | Choice of Control Group and Related Issues in Clinical trials | Prior to 2008 |
E11(R1) | Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population | 2017-11 |
E14 | The Clinical Evaluation of QT/QTc internal Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs | Prior to 2008 |
E14 Q&As (R3) | The Clinical Evaluation of QT/QTc internal Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs | Prior to 2008 |
E15 | Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories | 2017-11 |
E17 | General principles for planning and design of Multi-Regional Clinical Trials | 2017-11 |
E18 | Genomic Sampling and Management of Genomic Data | 2017-11 |
E19 | A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials | 2022-12 |
M1 | MedDRA - Medical Dictionary for Regulatory Activities | 2010-01 |
M3(R2) | Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals | 2009-06 |
M3(R2) Q&As (R2) | Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals | 2012-03 |
M4 Q&As (R3) | Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use | 2016-11 |
M4(R4) | Organisation including the Granularity document that provides guidance on document location and paginations | 2016-11 |
M4E | Q&As (R4): CTD on Efficacy | Since 2003 |
M4E(R2) | CTD on Efficacy | 2016-12 |
M4Q Q&As (R1) | CTD on Quality | Since 2003 |
M4Q(R1) | CTD on Quality | Since 2003 |
M4S Q&As (R2) | CTD on Safety | Since 2003 |
M4S(R2) | CTD on Safety | Since 2003 |
M7 | Mutagenic impurities | 2017-11 |
M7(R1) | Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk | 2017-11 |
M7(R2) | Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk | 2023-06 |
M9 | Biopharmaceutics Classification System-based Biowaivers | 2022-04 |