International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

The purpose of ICH is to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Harmonisation would lead to a more economical use of human, non-human animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.

ICH guidelines have been adopted as law in several countries, but are only used as guidance for the U.S. Food and Drug Administration.

In the 1980s, what is today the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation; International Council of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.

In 2015, International Conference on Harmonisation changed its name to the International Council for Harmonisation while becoming a legal entity in Switzerland. On 23 October 2015 ICH conducted their initial meeting of their new assembly.

The ICH has four major parts:

The Steering Committee, made of six ICH Parties, governs the ICH, determining the policies and procedures, selecting topics for harmonisation and monitoring progress of harmonisation initiatives. The ICH consists of:

The ICH Coordinators represents each ICH Party to the ICH Secretariat on a day-to-day basis.

The ICH Secretariat is primarily concerned with preparations for, and documentation of, meetings of the Steering Committee as well as coordination of preparations for Working Group (EWG, IWG, Informal WG) and Discussion Group meetings.

The ICH Working Groups are created by the Steering Committee when a new topic is accepted for harmonisation, and is charged with developing a harmonised guideline that meets the objectives outlined in the Concept Paper and Business Plan.

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