ICH’s mission is to make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines.

Launched in 1990, ICH is a unique undertaking that brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the United States.

Regulatory harmonisation offers many direct benefits to both regulatory authorities and the pharmaceutical industry with beneficial impact for the protection of public health. Key benefits include: preventing duplication of clinical trials in humans and minimising the use of animal testing without compromising safety and effectiveness; streamlining the regulatory assessment process for new drug applications; and reducing the development times and resources for drug development.

Harmonisation is achieved through the development of ICH Tripartite Guidelines. The Guidelines are developed through a process of scientific consensus with regulatory and industry experts working side-by-side. Key to the success of this process is the commitment of the ICH regulators to implement the final Guidelines.

Current ICH Terms of Reference (2000)

  • To maintain a forum for a constructive dialogue between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the EU, USA and Japan in order to ensure a more timely introduction of new medicinal products, and their availability to patients;
  • To contribute to the protection of public health from an international perspective;
  • To monitor and update harmonised technical requirements leading to a greater mutual acceptance of research and development data;
  • To avoid divergent future requirements through harmonisation of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products;
  • To facilitate the adoption of new or improved technical research and development approaches which update or replace current practices, where these permit a more economical use of human, animal and material resources, without compromising safety;
  • To facilitate the dissemination and communication of information on harmonised guidelines and their use such as to encourage the implementation and integration of common standards.

Advancing Harmonisation for Better Global Health

Although ICH’s initial focus was the development of Guidelines for use in the ICH regions, where previously the vast majority of new pharmaceutical products were developed, the face of drug development has become increasingly global since ICH’s inception in 1990. In response to a growing interest from beyond the ICH regions in the use of ICH Guidelines, the ICH Steering Committee (SC) took the first step in March 1999 of establishing the ICH Global Cooperation Group (GCG) as a subcommittee of the ICH SC.

In November 2003, new Terms of Reference and Rules were endorsed for the GCG with the aim of establishing partnerships beyond ICH regions to promote a better understanding of ICH Guidelines.

The scope of activities undertaken by the GCG is embodied in the mission statement adopted by all parties in May 2005:

"To promote a mutual understanding of regional harmonisation initiatives in order to facilitate the harmonisation
process related to ICH Guidelines regionally and globally, and to facilitate the capacity of drug regulatory
authorities and industry to utilise them."

In November 2005, five Regional Harmonisation Initiatives (RHIs) from across the globe were invited to participate in the GCG. The GCG was further expanded with the decision of the SC in October 2007 to also invite the participation of representatives from Drug Regulatory Authorities (DRAs) / Department of Health (DoH) that are either a major source of active pharmaceutical ingredients or clinical trial data.

In addition, as per a decision of the SC in November 2010, invited RHIs and DRAs/DoH may also nominate technical experts as active members of ICH Expert Working groups.

In June 2013, the ICH SC adopted a new format for the GCG which was incorporated into a standing agenda item of the SC agenda entitled Global Cooperation (GC) session. The GC session maintains past GCG arrangements regarding RHIs/DRAs/DoH participation and the scope of activities related to the implementation of ICH Guidelines and capacity building.

Current RHI and DRAs/DoH representatives are invited to participate in the ICH SC meeting and its GC session and listen to technical topics at the level of the Steering Committee at the biannual ICH meetings. 



"Coming together is a beginning. Keeping together is progress. Working together is success."

Henry Ford