EMEA Announces Statement of Intent Regarding eCTD and eSubmissions

EMEA has reinforced its position on implementing the electronic-only submission of information in support of marketing authorisation applications in the centralised procedure, and, ultimately, implementation of the Electronic Common Technical Document (eCTD) as the required format for electronic submissions, in two new documents dated 22 January 2008:

• EMEA implementation of electronic-only submissions and eCTD submissions in the centralised procedure: Statement of Intent
• EMEA implementation of electronic-only submissions and eCTD submissions in the centralised procedure: Statement of Intent - Questions and Answers relating to strategic and general aspects of the implementation

Some key points in the Statement of Intent and accompanying Q&A include:

• From 1 July 2008, the EMEA will accept electronic-only submissions, either in eCTD format or non-eCTD format (eCTD is the recommended electronic format), with no additional requirement for paper copies. By the deadline, all national competent authorities must accept electronic-only submissions, the format for these submissions being eCTD.
• From 1 January 2009, the EMEA will strongly recommend electronic-only submissions, either in eCTD or non-eCTD format (eCTD is the recommended electronic format), and paper will be an exception to the general e-format recommended for any application.
• From 1 July 2009, the EMEA will strongly recommend eCTD-format electronic-only
  submissions. Paper and other electronic formats will be an exception to the general e-CTD format recommended for any application.
• The EMEA is committed to the eCTD as the preferred format for submissions. Submitting any other electronic format may affect the quality and speed of the procedure and the feedback received.
• The Statement of Intent does not mean that eCTD submission must be mandatory in each Member State by the deadline; merely accepted without paper.
• EMEA stressed that these points apply only to the centralised procedure.

Key provisions include the establishment of a central repository and a single review tool for eCTDs submitted using the centralised procedure, which are necessary steps to eliminate the need for hard copies.

The EMEA gave some recommendations on implementing eCTD in the EU, and also has promised a further Q&A document on practical and technical aspects of eCTD implementation in the centralised procedure. During the February 7th International Regulatory Update session at the DIA Doc Management conference, Tim Buxton of the EMEA stated that this guidance will include the detailed process for submitting eCTD to the EMEA and will also discuss digital signatures.

Another key point stated by the EMEA is "The vendor market in eCTD builder tools and consultancy on all aspects of eCTD preparation and submission is mature, and companies should research these options, if applicable, for engaging external expertise. The EMEA is unable to list or recommend specific vendors. However, companies interested in gaining more information relating to software should contact pharmaceutical trade associations active in the EU for details of existing eCTD Topic Groups."

The planning horizon for full electronic-only implemention is now approaching the minimum time in which eCTD readiness can be fully achieved. It's time for sponsors doing business in Europe to become fully prepared if they are not eCTD-ready right now.