Pharma Qus: What is CTD? Ans: The Common Technical Document (CTD) - TopicsExpress



          

Pharma Qus: What is CTD? Ans: The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.
Posted on: Fri, 19 Jul 2013 17:40:07 +0000

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