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ICH- international council for harmonization of technical requirements for pharmaceuticals for human use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH mission is to achieve greater harmonization worldwide to ensure that safe, effective and high quality medicines are developed and registered in the most resource –efficient manner. Harmonization achievements in quality area include pivotal milestone such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more manufacturing practice (GMP) risk management. 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.


ICH, Hormonisation, ICH Guidelines, Stability Studies, Regulatory Guidelines.

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