Electronic Submissions (eCTD)

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eCTD - What you really need to know

  • eCTD is the standard abbreviation for 'electronic Common Technical Document' and refers to an internationally agreed standardised format for electronic submission of New Drug Applications (NDA) and Marketing Authorisation applications (MAA).
  • The FDA require eCTD format since 1st January 2008. The EMEA will accept electronic applications from 1st July 2008. From 1st July 2009, the EMEA will strongly recommend only eCTD-format submissions. The majority of EU competent authorities already accept eCTD and all are committed to accepting eCTD from 2009. eCTD will be the preferred format, with paper and other electronic formats being regarded as exceptional.
  • This applies to all applications (new and existing) and all types of submissions including new applications, responses to questions, variations and renewals.
  • AKOS operates a validated 'cutting edge' system for compiling eCTD applications. We can import client's data and prepare fully validated eCTD compliant applications.
  • AKOS offers full and expert Regulatory support during the NDA/MAA process, from strategic Regulatory planning through Gap Analysis, preparation of reports and dossiers and co-ordination of translations before producing the whole NDA/MAA in eCTD format.

eCTD - The process in more detail

Preparing an initial eCTD breaks down into four distinct areas:

1. Preparing CTD Modules 1-5

The requirement to prepare and submit applications according to the CTD (Common Technical Document) has been around for a number of years. Within eCTD the files which make up an application are linked to one another.

2. Preparing the documents

eCTD have very specific requirements relating to such things as font, font sizes, OCR (Optical Character Recognition), bookmarking and hyperlinking within the document and file security. In addition the file type (with some specific exceptions) has to be PDF (Portable Document Format).

Each document from CTD Modules 1 to 5 has to be suitably formatted then converted to PDF, possibly bookmarked and hyperlinked and then checked for compliance with the specifications. It is worth noting that Module 1 is both Region and Nation specific.

3. Compiling the Application

Each document must be given its correct name. The whole folder structure, including most folder names, is defined in the guidance. The various files then have to be examined for any required bookmarking or hyperlinking between files. Next the xml (Extensible Markup Language) files are prepared. These files act as the index to the application and highlight whether documents are new or replacements during the lifecycle of a product. The presence of xml files, or backbone, can be considered as the most significant difference between eCTD applications and CTD applications submitted electronically (NeeS - Non eCTD electronic Submissions).

The Regional and National nature of the Module 1 means that more than one eCTD may be needed for a particular product.

4. Publishing the application

The final act is to burn the application to CD or DVD.

This is a brief overview of a process that is simple to outline - but technically difficult to manage.

AKOS uses a dedicated software solution to provide a complete e-submission system; offering comprehensive publishing, compilation, review and printing capabilities.

The system used by AKOS conforms to all current ICH and US, EMEA, Canadian, Taiwanese and Japanese requirements, as stipulated in eCTD guidelines and specifications.

To discuss your regulatory questions with Akos please contact us:

Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk

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