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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.

Pharma IQ
Enusring 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 common technical document) as the preferred format for regulatory submissions....
Contributor: Pharma IQ
11/07/2010 07:00:00 PM EST
Embracing eCTDs and Electronic Submissions

In 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 mainstay in the industry for a long time, changing...

Contributor: Pharma IQ
10/20/2010 08:00:00 PM EDT
Pharma IQ

As 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 in prominence. Although its impact was first...

Contributor: Pharma IQ
08/09/2010 08:00:00 PM EDT