Welcome to the ICH official website

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Download the ICH 20th Anniversary Publication

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)

ICH Training

APEC AHC workshop on Q8/Q9/Q10 Guidelines

4-5 October 2011, Seoul, Republic of Korea

ICH Quality training on Q8/Q9/Q10 Guidelines

26-27 September 2011, Ottawa, Ontario, Canada

SADC workshop on the ICH Q7 Guideline

27-30 June 2011, Arusha, Tanzania

ASEAN workshop on the ICH Q5C Guideline

30-31 May 2011, Kuala Lumpur, Malaysia

Help to Shape the ICH Guidelines

 

by responding to one of our consultations. Your contribution will then be considered by the relevant ICH Working Group.

 

Draft Guidelines

Q&A Documents

Recent News

14 May 2012

The Steering Committee endorses the establishment of an S1 EWG

 

In April 2012, the Steering Committee approved the S1 Concept Paper and Business Plan...

10 May 2012

ICH Q11 reaches Step 4 of the ICH Process

 

The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical...

3 May 2012

Additional E14 Q&As available on the ICH website

 

In April 2012, the ICH E14 Implementation Working Group (IWG) finalised under Step 4 of...