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 Amsterdam, the Netherlands on 5 & 6 June 2019.

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

  • MedDRA Management Committee

    The MedDRA Management Committee met in Amsterdam, the Netherlands on 1& 2 June 2019.

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

  • New ICH Observer ANMAT, Argentina

    The ICH Assembly Chair and Vice Chair welcomed ANMAT, Argentina as a new ICH Observer at the Amsterdam meeting in June 2019.

     

    (L – R: Ms. Lenita Lindström-Gommers; Mr. Sebastian Duarte and Dr. Petra Doerr)

  • New ICH Observer JFDA, Jordan

    The ICH Assembly Chair and Vice Chair welcomed JFDA, Jordan as a new ICH Observer at the Amsterdam meeting in June 2019.

    (L – R: Dr. Wesal Haqaish; Ms. Lenita Lindström-Gommers; and Dr. Petra Doerr)

  • New ICH Observer SFDA, Saudi Arabia

    The ICH Assembly Chair and Vice Chair welcomed SFDA, Saudi Arabia as a new ICH Observer at the Amsterdam meeting in June 2019.

    (L – R: Ms. Lenita Lindström-Gommers; Dr. Mohammed A. Al Quwaizani and Dr. Petra Doerr)

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

14 June 2019

Press release ICH Assembly meeting in Amsterdam, the Netherlands, June 2019

 

The International Council for Harmonisation (ICH) met in Amsterdam, the Netherlands from ...

14 June 2019

Press release ICH MedDRA Management Committee meeting in Amsterdam, the Netherlands, June 2019

 

MedDRA Celebrates its 20th Anniversary The MedDRA Management Committee noted that 1...

12 June 2019

The ICH E8(R1) draft Guideline presentation available now on the ICH website

 

The ICH E8(R1) draft Guideline on General Considerations For Clinical Studies reached...