Medicines Healthcare Products Regulatory Agency
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 UKs 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 UKs 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)
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