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: M12 Drug Interaction Studies	Open	31 August 2022
Guideline Code: E11A Paediatric Extrapolation	Closed	30 June 2022
Guideline Code: Q2(R2)/Q14 Analytical Procedure Development and Revision of Q2(R1) Analytical Validation	Closed	30 June 2022
Guideline Code: Q9(R1) Quality Risk Management	Closed	31 March 2022
Guideline Code: M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk	Closed	15 January 2022

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	Prior to 2008
Q3D(R1)	Guideline for Elemental Impurities	2019-03
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	2006-01
Q7 Q&As	Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients	2006-01
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
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
M9	Biopharmaceutics Classification System-based Biowaivers	2022-04

Last updated: 31 Dec 2018