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CTD Dossiers



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).

eCTD:  Its electronic version called electronic Common Technical Document (eCTD)

eCTD composed of two types of specificatios

  • Content Specification—-As defined by ICH
  • Technical Specification—-Electronic Software’s

The Common Technical Document is divided into five modules :-

ctd

  • Module 1 : Administrative information and prescribing information
  • Module 2 : Common Technical Document Summaries (Overview and summary of modules 3 to 5)
  • Module 3 : Quality
  • Module 4 : Preclinical Study Reports
  • Module 5 : Clinical Study Reports (Clinical studies)

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