International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

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The aim of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to harmonize the assessment criteria of human drugs as the basis for drug approval in Europe , the USA and Japan .

The program runs parallel to the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (counterpart in veterinary medicine ).

structure

The ICH was founded in 1990 under the name International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use , by the American Food and Drug Administration (FDA), the European Commission (now together with the European Medicines Agency EMA), the Japanese Ministry of Health, Labor and Social Welfare (MHLW) and the drug manufacturers' associations Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA) and Japan Pharmaceutical Manufacturers Association (JPMA). The World Health Organization , EFTA and Canada have observer status. The ICH Secretariat is based in Geneva.

tasks

In a multi-stage process, the ICH develops uniform, recommended guidelines for the evaluation of the quality, efficacy and harmlessness of medicinal products. These include, for example, Good Clinical Practice (GCP) guidelines for clinical studies with pharmaceuticals, Good Manufacturing Practice (GMP) guidelines for faultless manufacturing practice, as well as guidelines for the standardization of medical terminology ( MedDRA ) or information transfer ( ESTRI ) in the regulatory area . The standardized format for the submission of approval documents, the Common Technical Document, is also of great importance . The ICH guidelines are adopted in the European Union by the responsible committee for medicinal products for human use (CHMP) at the EMA. The guidelines are therefore guidelines from which pharmaceutical companies should only deviate in justified cases.

Web links

  • ICH : Website of the International Council for Harmonization