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 Montreal, Canada on May 31 to June 1, 2017.

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

  • ICH Assembly Chair & Vice Chair

    ICH Assembly Vice Chair Dr. Toshiyoshi Tominaga (MHLW/PMDA, Japan) and Assembly Chair Ms. Lenita Lindström-Gommers (EC, Europe) who were elected by the ICH Assembly for a two-year term until November 2017.

  • ICH Management Committee Chair & Vice Chair

    ICH Management Committee Vice Chair Dr. Toshiyoshi Tominaga (MHLW/PMDA, Japan) and ICH Management Committee Chair Dr. Theresa Mullin (FDA, US) who were elected by the ICH ICH Management Comittee for a one-year term until November 2017.

  • New ICH Regulatory Member CDFA, China

    The ICH Assembly Chair and Vice Chair, along with the ICH Management Committee Chair, welcome CFDA, China, as ICH’s newest ICH Regulatory Member.

    (L – R: Mr. Wang Xiangyu; Ms. Lenita Lindström-Gommers; Dr. Toshiyoshi Tominaga; Dr. Theresa Mullin; Mr. Yuan Lin;and Ms. Liu Yuan)

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 ICH.

 

Draft Guidelines

Q&A Documents

GCP Renovation

Recent News

18 October 2017

The E18 presentation available now on the ICH website

 

The ICH E18 Guideline on Genomic Sampling and Management of Genomic Data provides...

17 October 2017

ICH releases finalised, draft Guidelines and publishes working party membership for first time

 

Following its last meeting in Montreal in June 2017, the International Council for...

13 October 2017

The ICH S5(R3) draft Guideline presentation available now on the ICH website

 

The ICH revised S5(R3) draft Guideline on Detection of Toxicity to Reproduction for Human...