# International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/ef01de18-9fd5-4daa-85ee-566c28da7ae0 Type: Detailed Guide Published: April 3, 2024 Updated: May 19, 2026 > This document outlines the current directory of international standards adopted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) following the United Kingdom's exit from the European Union. Since becoming a full member of the International Council for Harmonisation (ICH) in May 2022, the MHRA has formally implemented a wide array of guidelines originally managed under the EU system. These standards are maintained under the regulatory framework of the Human Medicines Regulations 2012. The primary objective of these guidelines is to ensure that pharmaceutical products are developed and registered with high standards of safety, quality, and efficacy in a resource-efficient manner. The directory categorizes requirements into four key areas: Quality (covering stability, impurities, and manufacturing), Safety (addressing toxicity and carcinogenicity), Efficacy (detailing clinical trial protocols and safety reporting), and Multidisciplinary (standardizing electronic documentation and medical terminology). While this specific document does not detail individual company violations or inspection dates, it establishes the mandatory technical expectations for all pharmaceutical companies seeking to register medicines in the UK. Manufacturers and developers must adhere to these harmonized best practices to ensure their products meet the rigorous safety and quality benchmarks required for market authorization. --- ## Content 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 Q6A – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6B – Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7 – Questions and Answers Q8(R2) – Pharmaceutical Development Q9(R1) – Quality Risk Management Q10 – Pharmaceutical Quality System Q11 – Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11 – Questions and Answers Q13 – Continuous Manufacturing of Drug Substances and Drug Products 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(R3) – Guideline for Good Clinical Practice E7 – Studies in Support of Special Populations: Geriatrics E7 – Questions and Answers E8(R1) – General Considerations for Clinical Studies 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 M13A – Bioequivalence for Immediate-Release Solid Oral Dosage Forms