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pepgra on 08 Mar 18The Common Technical Document (CTD) is an international standard for the summary documents relating to quality, safety and efficacy information of medicinal products. The CTD is mandatory for the registration of medicines. International Council for Harmonization (ICH) mandates to obtain regulatory approval of new drug applications of Pharmaceutical companies operating in European Union states. The main aim of CTD is to achieve greater harmonization in new drugs development and registration. The standard encompasses the entire spectrum of documentation to be integrated into a regulatory submission dossier, thereby offering complete guidance to pharmaceutical companies as to how formulation and manufacturing information supporting the quality parameter as well as the results of non-clinical and clinical research needs to be organized and presented.