Submissions made in Non-eCTD electronic Submissions (NeeS) or electronic Common Technical Document (eCTD) format have been mandatory since January 2010 in the EU.
This follows further development of the CTD submission process, which initially involved NtA to CTD, and then further standardisation by the International Conference for Harmonisation (ICH) to announce electronic CTD submission requirements. For Centralised procedures eCTD format is mandatory, for all other procedures, such as Mutually Recognised Products (MRP), Decentralised Products (DCP), and National products, it is recommended that eCTD format is used. This requirement eliminates the need for paper filings: reducing paper flow, the volume of physical archiving, and improving the review process. eCTD submissions are mandatory in the USA.
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.
Electronic Common Technical Documents (eCTD) are mandatory for submissions to the FDA. Other authorities including the EMA welcome eCTD as the preferred format for all regulatory submissions. 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
• Smaller amounts of content of a dossier
• Re-using content of a dossier
• Reduction in paper
• Being able to view with ease the life-cycle of all the documents and submissions, which has not always
been possible in the past.
The actual structure of the eCTD is identical to the already well-used CTD.
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 and during licence maintenance, only the information that has been changed needs to be submitted, as the assessor is able to view all of 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 (eg. application and sequence number)
How Woodley BioReg can help with ECTD Publishing?
Woodley BioReg can assist with all aspects of CTD submissions and recognise that the preparation of files in individual PDF can be a long and tedious process, requiring a high degree of attention to detail. One of the most common reasons for the rejection or delay in the assessment of a file is incorrect or illegible PDF conversion. Woodley BioReg’s conversion process ensures the accurate and efficient creation of eCTD files (for MAAs, INDs, ANAs, etc.) and the management of electronic submissions.
We provide NeeS and eCTD preparation and publishing services for all sectors of the pharmaceutical, biopharmaceutical and healthcare industry. Many of our clients have established products registered using earlier submission frameworks, such as NtA, that we provide extraction and conversion services into eCTD format for on-going License Maintenance.
Publishing Software Solutions
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ’s solutions are geared specifically for submission assembly, review, publishing, validation and management. As the number one supplier of submission management systems in the world, as well as the largest supplier of eCTDs for U.S., European and Japanese submissions in the world, LORENZ is the technological market leader. With over 200 installations in 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.
For more information, help and advice on eCTD publishing please contact us.