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The ICH, originally the "International Conference on Harmonization," was established in 1990 by the FDA, the European Commission, the Japanese Ministry of Health, and major pharmaceutical industry associations. Based in Geneva, the ICH develops standardized guidelines for the quality, efficacy, and safety of pharmaceuticals, such as GCP or GMP. These guidelines serve as directives for the pharmaceutical industry. Observers include the WHO (World Health Organization) and EFTA (European Free Trade Association). In the EU, the guidelines are adopted by the EMA (European Medicines Agency) and are considered standards from which pharmaceutical companies should deviate only in exceptional cases.

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