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."

eCTD is already mandatory in America (FDA) and the Czech Republic with many other countries strongly recommending its use.

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 and Life Cycle Management 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.