electronic Common Technical Document (eCTD)

In December 2008 the EMEA published a press release in which they state:

"From 1 January 2010, the EMEA will mandate the use of eCTD format for all electronic-only submissions for all applications (new and existing) and all submission types. Rapporteurs and CHMP members will not receive paper copies or other electronic formats."

The advantages of eCTD are:

  • electronic submissions (CD/DVD or Secure Electronic Gateway) reducing the need for paper documentation
  • hyperlinks and bookmarks make it easy to navigate through the dossier and documentation
  • the eCTD tool automatically creates the Table of Contents
  • the Table of Contents includes descriptive information
  • Life Cycle Management for dossiers and documents
  • documents are submitted only once with future amendments cross-referring to information in previous eCTDs
  • easy to copy sections of a dossier to adapt for specific country requirements

Our professional associates use state-of-the-art publishing software and have published numerous electronic submissions in eCTD and non-eCTD electronic submission (NEES) formats ranging from Clinical Trial Applications (CTAs) to full Marketing Authorisations (MAs). If you don’t have the resource for eCTD publishing in-house, please be assured that Global Regulatory Services can provide you with the appropriate support, expertise and technical know-how.

Please contact us with your specific eCTD regulatory compliance requirements.