All regulatory submissions are made in Non-eCTD electronic Submissions (NeeS) or electronic Common Technical Document (eCTD) format. eCTD format submissions have been mandatory in the EU since January 2010.
Non-eCTD electronic Submissions (NeeS) represent a national requirement rather than an internationally accepted standard.
NeeS are based on granular PDF files, electronic tables of contents, and electronic navigation using bookmarks and hyperlinks, which are defined by country specific guidelines. NeeS do not use the XML backbone, which is used in eCTD submissions.
Typically NeeS submissions are requested in markets outside the EU, US, and Japan where the national agency systems may not be fully set-up and validated to accept eCTD.
Electronic Common Technical Documents (eCTD) are mandatory for submissions to the EMA, UK-MHRA, and the FDA. The key advantage of eCTD are:
- Data exchange to ease the review process, so reviewers and submitters look at submissions via a common web browser
- Re-using content of a dossier
- Reduction in paper
- Being able to view the life cycle of all the documents and submissions with ease — this has not always been possible previously
In eCTD the XML backbone replaces the CTD Table of Contents (TOC). This allows management of the meta-data or descriptive information for the entire submission and provides a navigation aid to access all the documents within a submission.
The tabs in eCTD are equivalent to folders or files in CTD, for the sub-division of paper dossiers. eCTD uses hyperlinks instead of cross-referencing for easy access between documents and submissions. As an electronic file, the size of this is the main consideration rather than the number of pages.
eCTD submissions enable applicants to submit documents just once. During licence maintenance, only the information that has been changed needs to be submitted, as the assessor is able to view all the information previously submitted.
eCTD publishing is the final compilation of regulatory documents as an electronic submission and typically includes:
- Assignment of documents to a location within the eCTD modular structure
- PDF rendering of the final, hyperlinked documents
- Customisation of document headers and footers
- Assigning eCTD titles and grouping study-related files
- Set up of submission-specific values (e.g. application and sequence number)
- eCTD submission validation