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 Kobe, Japan on 6 & 7 June 2018.

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

  • MedDRA Management Committee

    The MedDRA Management Committee met in Kobe, Japan on 2 & 3 June 2018.

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

  • New ICH Management Committee (MC) Members

    The ICH MC Chair and Vice Chair welcomed five new ICH Members to the ICH MC in Kobe, Japan, June 2018. Three regulatory members: CFDA, China; HSA, Singapore and MFDS, South Korea. And two industry members: BIO and IGBA.

  • New ICH Regulatory Member TFDA, Chinese Taipei

    The ICH Assembly Chair and Vice Chair welcomed TFDA, Chinese Taipei as ICH’s newest Regulatory Member at the Kobe meeting.

    (L – R: Ms. Chao-Yi Wang; Ms. Yi-Jing Kuo; Ms. Lenita Lindström-Gommers; Ms. Hsiao-Han Chiang; Dr. Toshiyoshi Tominaga and Dr. Churn-Shiouh Gau)

  • New ICH Observer NPRA, Malaysia

    The ICH Assembly Chair and Vice Chair welcomed NPRA, Malaysia as a new ICH Observer at the Kobe meeting.

     

    (L – R: Dr. Ramli Zainal; Ms. Lenita Lindström-Gommers; and Dr. Toshiyoshi Tominaga)

  • New ICH Observer TİTCK, Turkey

    The ICH Assembly Chair and Vice Chair welcomed TITCK, Turkey as a new ICH Observer at the Kobe meeting.

    (L – R: Ms. Nihan Burul Bozkurt; 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)

  • 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

 

Your contribution will be considered by ICH for the following documents currently under consultation:

 

Draft Guidelines

Q&As

GCP Renovation

Recent News

25 October 2018

The ICH Q3C(R7) Guideline and Q3C Support Documents available now on the ICH website

 

The ICH Q3C(R7) Guideline, which is the result of an error correction of the Permitted...

18 October 2018

The ICH S11 draft Guideline presentation available now on the ICH website

 

The ICH S11 draft Guideline on Nonclinical Safety Testing in Support of Development of...

31 August 2018

The ICH M9 draft Guideline presentation available now on the ICH website

 

The ICH M9 draft Guideline on Biopharmaceutics Classification System-based...