International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines

About ICH 

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) aims to create an international collaborative network where people can bring forth best practices from their countries, learn from other countries, and implement best practices in their own country. It brings together the regulatory bodies and pharmaceutical industry to look at the scientific and technical aspects of drug registration.

The group discusses the scientific and practical aspects of pharmaceuticals, producing guidelines in four areas – ‘safety’, ‘quality’, ‘efficacy’ and ‘multidisciplinary’. The development and subsequent implementation of these guidelines aims to achieve global harmonisation. The overall aim of ICH is to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. 

Before the UK’s exit from the EU, the MHRA was part of ICH under the EU system. Guidelines in use at that time were carried over as EU guidance documents referred to in the Human Medicines Regulations 2012.

Following the UK’s exit from the EU, MHRA became a full Member of ICH in May 2022. This page serves as a directory for current ICH Guidelines which have been implemented by the MHRA.

This page will be updated as new guidelines are implemented by the MHRA.

Quality Guidelines

• Q1A(R2) – Stability Testing of New Drug Substances and Products
• Q1B – Stability Testing: Photostability Testing of New Drug Substances and Products
• Q1C – Stability Testing for New Dosage Forms
• Q1D – Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
• Q1E – Evaluation of Stability Data
• Q3A(R2) – Impurities in New Drug Substances
• Q3B(R2) – Impurities in New Drug Products
• Q3D(R2) – Guideline for Elemental Impurities
• Q4B – Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions
• Q4B Annex 1(R1) – Residue on Ignition/Sulphated Ashe General Chapter
• Q4B Annex 2(R1) – Test for Extractable Volume of Parenteral Preparations General Chapter
• Q4B Annex 3(R1) – Test for Particulate Contamination: Sub-Visible Particles General Chapter
• Q4B Annex 4A(R1) – Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
• Q4B Annex 4B(R1) - Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
• Q4B Annex 4C(R1) - Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
• Q4B Annex 5(R1) Disintegration Test General Chapter
• Q4B Annex 6 – Uniformity of Dosage Units General Chapter
• Q4B Annex 7(R2) – Dissolution Test General Chapter
• Q4B Annex 8(R1) – Sterility Test General Chapter
• Q4B Annex 9(R1) – Tablet Friability General Chapter
• Q4B Annex 10(R1) – Polyacrylamide Gel Electrophoresis General Chapter
• Q4B Annex 11 – Capillary Electrophoresis General Chapter
• Q4B Annex 12 – Analytical Sieving General Chapter
• Q4B Annex 13 – Bulk Density and Tapped Density of Powders General Chapter
• Q4B Annex 14 – Bacterial Endotoxins Test General Chapter
• Q5B – Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
• Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
• Q5D – Derivation and Characterisation of Cell Substrates Used for Productions of Biotechnological/Biological Products
• Q5E – Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

Safety Guidelines

• S1A – Need for Carcinogenicity Studies for Pharmaceuticals
• S1B(R1) – Testing for Carcinogenicity of Pharmaceuticals
• S1C(R2) – Dose Selection for Carcinogenicity Studies of Pharmaceuticals
• S2(R1) – Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
• S3A – Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
• S3A – Questions and Answers
• S3B – Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
• S4 – Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)
• S5(R3) – Revision of S5 Guidelines on Detection of Toxicity to Reproduction for Human Pharmaceuticals
• S6(R1) – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
• S7A – Safety Pharmacology Studies for Human Pharmaceuticals
• S7B – The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
• S8 – Immunotoxicity Studies for Human Pharmaceuticals
• S9 – Nonclinical Evaluation for Anticancer Pharmaceuticals
• S10 – Photosafety Evaluation of Pharmaceuticals
• S11 – Nonclinical Safety Testing in Support of Development of Paediatric Medicines

Efficacy Guidelines

• E1 - The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions
• E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• E2B(R3) – Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs)
• E2B(R3) – Questions and Answers
• E2C(R2) – Periodic Benefit-Risk Evaluation Report
• E2C(R2) – Questions and Answers
• E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
• E2E – Pharmacovigilance Planning
• E2F – Development Safety Update Report
• E3 – Structure and Content of Clinical Study Reports
• E3 – Questions and Answers (R1)
• E4 – Dose-Response Information to Support Drug Registration
• E5(R1) – Ethnic Factors in the Acceptability of Foreign Clinical Data
• E5 – Questions and Answers
• E6(R2) – Good Clinical Practice (GCP)
• E7 – Studies in Support of Special Populations: Geriatrics
• E7 – Questions and Answers
• E9 – Statistical Principles for Clinical Trials
• E9(R1) – Addendum: Statistical Principles for Clinical Trials
• E10 – Choice of Control Group and Related Issues in Clinical Trials
• E11(R1) – Clinical Investigation of Medicinal Products in the Pediatric Populations: Guideline and Addendum
• E14 – The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
• E14 – Questions and Answers (R3)
• E15 – Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
• E16 – Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions
• E17 – General Principles for planning and design of Multi-Regional Clinical Trials
• E18 – Genomic Samples and Management of Genomic Data

Multidisciplinary Guidelines

• M1 – MedDRA – Medical Dictionary for Regulatory Activities
• M3(R2) – Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
• M3(R2) – Questions and Answers (R2)
• M4(R4) – Organisation Including the Granularity document that provides guidance on document location and paginations
• M4 – Questions and Answers (R3)
• M4Q(R1) – CTD on Quality
• M4Q – Questions and Answers (R1)
• M4S(R2) – CTD on Safety
• M4S – Questions and Answers (R2)
• M4E(R2) – CTD on Efficacy
• M4E – Questions and Answers (R4)
• M7(R2) – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
• M7(R2) – Addendum Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
• M8 – Electronic Common Technical Document (eCTD) v3.2.2
• M8 – Electronic Common Technical Document (eCTD) v4.0
• M9 – Biopharmaceutics Classifcation System-based Biowaivers
• M9 – Questions and Answers
• M10 – Bioanalytical Method Validation and Study Sample Analysis