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 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, 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

PDA-PIC/S Training on ICH Q7 Guideline

10-12 February 2015, Brasilia, Brazil

PDA-PIC/S Training on ICH Q7 Guideline

22-23 January 2015, Seoul, Republic of Korea

Workshop on the ICH M7 Guideline

29 September 2014, Tokyo, Japan

PDA-PIC/S Training on ICH Q7 Guideline

18-19 September 2014, Brussels, Belgium

Help to Shape the ICH Guidelines

 

currently under consultation. Your contribution will then be considered by the relevant ICH Working Group.

 

Draft Guidelines

Q&A Documents

Recent News

2 December 2014

Press release ICH Steering Committee meeting in Lisbon, November 2014

 

The SC agreed on the key issues relating to the reform of ICH in terms of governance, new...

4 November 2014

Agenda Papers for the upcoming ICH SC meeting available for download

 

The Steering Committee will meet in Lisbon, Portugal from 8 to 13 November to discuss...

17 September 2014

Follow in details the main decisions taken by the ICH SC in June 2014

 

A comprehensive report of the last ICH meeting that was held in Minneapolis, MN, USA on...