Pharma IQ Glossary: Electronic Common Technical Document (eCTD)
Electronic Common Technical Document (eCTD) is a message specification for the transfer of files and metadata from a submitter to a receiver. The content is based on the Common Technical Document (CTD) format. It was developed by the International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). The eCTD has five modules: Administrative Information and Prescribing Information, Common Technical Document Summaries, Quality, Nonclinical Study Reports and Clinical Study Reports.
eCTD Transforms Pharma
November 08 by Pharma IQEnusring eCTD readiness is now a major concern for all pharmaceutical companies seeking to gain first time approval, as more regulators move towards the eCTD (electronic commo...
Embracing eCTDs and Electronic Submissions
October 20 by Pharma IQIn the past few years, the very way pharmaceutical organisations submit their applications for drug approval has become an essential issue to consider. While paper-based submissions have been a m...
eCTD Rises in Popularity Across Europe
August 09 by Pharma IQAs a growing number of industry authorities confirm that they only intend to accept documents for approval in electronic form, the concept of the electronic common technical document (eCTD) has risen...
