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Research Article Open Access
Harmonisation of regulatory requirements was initiated by the European Community (EC), in the 1980s, the EC moved towards the development of a single market for pharmaceuticals. At the same time there were bilateral discussions between Europe, Japan and the US on possibilities for harmonisation. ICH is a unique undertaking that brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the United States. ICH guideline gives special concern for the patient population; large-scale human clinical trials lasting up to one year can begin in the absence of completed carcinogenicity studies in rodents. ICH regulatory authorities are among the first to evaluate new chemical entities and new products obtained from biotechnology. ICH provides various guidelines which are categorised into four category, Quality guidelines, safety guidelines, efficacy guidelines and multidisciplinary guidelines. These guideline give special concern for the patient population, large-scale human clinical trials lasting up to one year can begin in the absence of completed carcinogenicity studies in rodents. The major aim of ICH To achieve greater harmonization in the interpretation and application of technical guidelines for the registration of new active substances or products obtained by biotechnology by its members; to improve the efficiency of global drug development; to reduce redundant studies; and to improve pharmacovigilance activities and quality assurance.
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Author(s): Ankit Gupta, Raghav Goel, Suresh Jain, Vipin Saini
Clinical trial, ICH, impact, guidelines, steering committee (SC), General Care Taken for Mother and Child,Pharmaceutical Sciences