"The International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use" (ICH) was established in 1990 as a joint regulatory/industry effort to improve, through harmonization, the efficiency of the process for developing and registering good quality, safe and effective new pharmaceutical products in Europe, Japan, and the United States. These activities, as stated in the 1990 Terms of Reference, "...are pursued in the interest of the consumer and public health to prevent unnecessary duplication of clinical trials in humans and to minimize the use of animal testing without compromising the regulatory obligations of safety and effectiveness."

From the outset, the ICH Steering Committee recognised the need to ensure that the harmonization process was conducted in an open and transparent manner and that the benefits of harmonization be available world-wide. To that end, representatives of WHO, Canada, and EFTA were made permanent ﾒobserversﾓ to the Steering Committee. Efforts have been taken to ensure transparency of the process by means of conferences, web sites, and publications.

It was not possible to predict the success of the ICH. Over forty harmonised guidelines have been developed in the areas of quality, safety, and efficacy - and more recently, tools for regulatory communication (the Medical Dictionary, MedDRA, and the electronic gateway standards, ESTRI) have been harmonized and made available.

In 1997, ICH completed its first phase of activities. In a Statement on the Future of ICH, the Steering Committee recognised the considerable growing interest of regulatory and industry bodies outside the three ICH and observer regions. In order to focus attention on the needs and interests of non-ICH countries in ICH activities and to provide recommendations for action, the ICH Steering Committee created a Subcommittee to focus on the issue of globalisation. At its first meeting in October 1999, the ICH Global Cooperation Group began the task of developing its Terms of Reference and the framework for a work program. First and foremost was recognition that this activity must be conducted co-operatively with the WHO, in agreement with its harmonization program and efforts. For its part, WHO has identified the need for greater attention to harmonization and the ICH activity among member countries. The Ninth International Conference of Drug Regulatory Authorities Meeting (ICDRA), 1999, recommended increased utilization of the ICH guidelines, including for education and training purposes, as appropriate for relevant member states. ICDRA also recommended to the ICH Steering Committee that it become increasingly aware of and responsive to developing country needs. Research on new products is not confined to the three ICH regions. Clinical trials are carried out throughout the world and many non-ICH countries are establishing a research base. The existence of published harmonised guidelines means that scientists throughout the world have the advantage of knowing the technical standards that will be acceptable if the medicinal products they are developing are destined for the global market. The ICH guidelines are readily available as teaching tools to facilitate this expansion and the growing regional harmonization efforts. The Global Cooperation Group proposes to develop a work program that is responsive without imposing ICH guidelines on non-ICH countries. This challenge will also need to consider the expectations of the WHO and the recommendations of the ICDRA. Of paramount importance is a recognition by the ICH sponsors that close co-operation with WHO and support for WHO efforts is critical to ensure that the ICH achievements are readily available to all.