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The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss the scientific and technical aspects of pharmaceutical development. 

Through working groups of regulatory and industry experts, ICH produces harmonised technical requirements to ensure the development and registration of safe, effective, and high-quality medicines. Technical guidelines are developed through scientific consensus, with public consultation. 

ICH Guidelines are adopted by regulatory authorities and published on the ICH website.

ICH also produces a standardised reference tool for medical terminology (MedDRA) in 27 languages and electronic standards for the transfer of regulatory information (ESTRI).

Founded 35 years ago and registered as a non-profit legal entity under Swiss law in 2015, ICH has finalised nearly 80 Guidelines that are applied by regulatory authorities around the world. ICH has 25 members, 41 observers, and a network of close to 700 experts globally. 

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ICH51 in Singapore
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ICH51 in Singapore
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The ICH Assembly met on 18-19 November 2025 in Singapore. For more information on the meeting, please see the Press Release.

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ICH Assembly Welcomes New Members and Observers at ICH51
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Representatives of new Members and Observers with Assembly Chair & Vice-Chair
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ICH welcomed two new Members, NAFDAC, Nigeria and SAHPRA, South Africa, and two Observers, DIGEMAPS, Dominican Republic and Philippine FDA, Philippines at ICH51 in Singapore. >> Read more

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ICH Assembly Welcomes New Members and Observers
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2025 DIA Regional Inspire Award for ICH
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Award
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ICH receives the Outstanding Contribution to Health Award at the DIA Europe meeting March in Basel 2025

For more information, please see the News section.

 

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

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View All Quality Guidelines
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Safety Guidelines
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Safety Guidelines
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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)

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Efficacy Guidelines
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Efficacy Guidelines
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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)

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Multidisciplinary Guidelines
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Multidisciplinary Guidelines
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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)

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M4: CTD
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M4: CTD
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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)

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M1: MedDRA
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M1: Meddra
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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)

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Upcoming Events
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ICH Guideline Database
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Search tools are available for easy retrieval of information on ICH Guidelines:

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Help to Shape the ICH Guidelines
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Your contribution will be considered by ICH for the documents currently under consultation available on this page.

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