Welcome to the ICH official website

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation. To Learn More: ICH Organisational Changes

ICH Organisation Changes

Discover ICH Products

  • Quality Guidelines

    Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities... (more)

  • Safety Guidelines

    ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy ... (more)

  • Efficacy Guidelines

    The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines... (more)

  • Multidisciplinary Guidelines

    Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories.  It includes the ICH medical terminology (MedDRA)... (more)

  • M4: CTD

    The agreement to assemble all the Q, S, and E information in a common format (called CTD - Common Technical Document) has revolutionized the regulatory review processes... (more)

  • M1: MedDRA

    MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. ... (more)

Help to Shape the ICH Guidelines


currently under consultation. Your contribution will then be considered by the relevant ICH Working Group.


Draft Guidelines

Q&A Documents

Recent News

19 October 2016

New ICH M10 Guideline in development on Bioanalytical Method Validation


In October 2016, the ICH endorsed a new topic on the validation of bioanalytical methods...

19 October 2016

New ICH M9 Guideline in development on Biopharmaceutics Classification System (BCS)-based biowaivers


In October 2016, the ICH endorsed a new topic for the development of a new...

19 October 2016

ICH E11(R1) draft Guideline reaches Step 2b of the ICH Process


The ICH E11(R1) draft Addendum Guideline on Clinical Investigation of Medicinal Products...