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)

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 <Guideline Code> Feedback.

Draft ICH Guidelines             

Status for consultation

Deadline for comments

Guideline Code: E20

Stability Testing of Drug Substances and Drug Products

Open30 November 2025

Guideline Code: Q3E

Adaptive Designs for Clinical Trials

Open30 November 2025

Guideline Code: M4Q(R2)

Revision of M4Q(R1)

Open30 November 2025

Guideline Code: Q1

Stability Testing of Drug Substances and Drug Products

Closed11 July 2025

Guideline Code: M13B

Bioequivalence for Immediate-Release Solid Oral Dosage Forms

Closed15 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

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