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 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

18-19 September 2014, Brussels, Belgium

DIA ICH training E2 Pharmacovigilance Guidelines

28-29 November 2013, Zagreb, Croatia

DIA ICH training E2 Pharmacovigilance Guidelines

22-23 September 2013, Muscat, Sultanate of Oman

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

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...

15 August 2014

Press Release: Bids Invited for MedDRA Maintenance & Support Services Contract

 

The ICH is conducting a Call for Tender for the MedDRA Maintenance and Support Services...

21 August 2014

The Steering Committee endorses the establishment of new Efficacy EWGs

 

The SC approved the ICH Efficacy EWGs to work on addenda for E6 on GCP and E11 on...