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. 

  • ICH Assembly

    The ICH Assembly met in Geneva, Switzerland on 15 & 16 November 2017.

    For more information on the meeting, see the ICH Press Release.

  • MedDRA Management Committee

    The MedDRA Management Committee met in Geneva, Switzerland on 11 & 12 November 2017.

    For more information on the meeting, see the MedDRA Press Release.

  • ICH Assembly Chair & Vice Chair

    ICH Assembly Chair Ms. Lenita Lindström-Gommers (EC, Europe) and Vice Chair Dr. Toshiyoshi Tominaga (MHLW/PMDA, Japan) were re-elected by the ICH Assembly for a two-year term until November 2019.

  • ICH Management Committee Chair & Vice Chair

    ICH Management Committee Chair Dr. Theresa Mullin (FDA, US) and Vice Chair Dr. Toshiyoshi Tominaga (MHLW/PMDA, Japan) were re-elected by the ICH Management Comittee for a one-year term until November 2018.

  • New ICH Regulatory Member HSA, Singapore

    The ICH Assembly Chair and Vice Chair, along with the ICH Management Committee Chair, welcomed HSA, Singapore, as ICH’s newest Regulatory Member at the Geneva meeting.

    (L – R: Dr. Theresa Mullin; Dr. Dorothy Toh; Ms. Lenita Lindström-Gommers; and Dr. Toshiyoshi Tominaga)

  • New ICH Observer Bill & Melinda Gates Foundation

    The ICH Assembly Chair and Vice Chair, along with the ICH Management Committee Chair, welcomed the Bill & Melinda Gates Foundation as a new ICH Observer at the Geneva meeting.

    (L – R: Dr. Theresa Mullin; Dr. Murray Lumpkin; Ms. Lenita Lindström-Gommers; and Dr. Toshiyoshi Tominaga)

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)
    View All Quality Guidelines

  • 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)

    View All Safety Guidelines

  • 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)
    View All Efficacy Guidelines

  • 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)
    View All Multidisciplinary Guidelines

  • 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 ICH.

 

Draft Guidelines

Q&A Documents

GCP Renovation

Recent News

30 April 2018

The ICH S9 Q&As reaches Step 4 of the ICH Process

 

The ICH S9 Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals reached Step...

31 January 2018

The ICH Assembly and MC Reports from the Geneva meeting, November 2017, available now on the ICH Website

 

In November 2017, the ICH Assembly and Management Committee met in Geneva, Switzerland,...

30 November 2017

Press release ICH MedDRA Management Committee meeting in Geneva, Switzerland, November 2017

 

The MedDRA Management Committee met in Geneva, Switzerland on 11-12 November 2017. Ms....