As part of our consulting work in drug development we frequently get involved in the production of Regulatory Documentation, often directing and managing the process. Regulators are now preferring the use eCTD format, this is a trend that will only get more important as time goes on and people developing drugs will need to start to think and implement these process if they are not already doing so. It is a global movement in 2000 the ICH agreed a eCTD format that is being taken up globally, in Europe it is set to become mandatory in 2010 with the USA and Canada following shortly after.

The number of eCTD applications being submitted is on the increase, there has been a 300% increase between Dec 2007 and Dec 2008, unfortunately however this is coming at a cost and that is in terms of errors being made. But the majority of these errors can be avoided, through good planning and QC processes.

Basics of eCTD:

The eCTD is built using specialist software, the output follows the module format we are familiar with, but the document uses an XML backbone to generate and maintain a table of contents (TOC), this TOC is bookmarked and hyperlinked so the reader can navigate and move through the document with ease.

Benefits of eCTD

Less physical storage space than conventional paper documents (less money on space and security)

Less time to move and update (again massive cost savings to be made)

Hugely efficient for review bodies to deal with (speeded up review times and reduce errors)

The status of the document can be easily monitored (money savings, time savings, and error reduction)

Global re-formatting is fast and simple (reduced and cost and time)

Current Status

There has been a huge rise in the number of eCTD’s being submitted, however with anything new there have been a large number of errors, most likely broken hyperlinks and failing TOC’s. The regulatory authorities have turned a blind eye to these errors as the other benefits have easily overcome these and the process is still new to so many. However this period of grace appears to be running out.

“its been 6 months since the CDER division of the FDA started requiring all electronic submissions to use the eCTD format, and all is not well” – Ann Neuer, The eCTD a six month checkup, BioIT-World 28th July 2008

How to avoid errors

• Early planning and preparation
• Appreciation of regulatory requirements
• Understanding of the appropriate regulatory guidance
• Knowledge of eCTD format and content
• Knowledge of the country specific eCTD requirements
• Knowledge of the eCTD e-submission processes
• Utilising the appropriate tools
• Consistent attention to detail
• QC / QA processes in place before you start
• You need to publish regularly to ensure problems are not arising.

Guidance Documents

there are a number of guidance documents available for review.

EMEA -http://esubmission.emea.europa.eu/doc/index.html

FDA – http://www.fda.gov/cder/regulatory/ersr/default.htm

Canada -http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/draft_ebauche_prep_ectd_format_rev-eng.php

It is important that you check these sites regularly to ensure you are up to date with requirements.

Good Practice

There are a number of processes and tools that can be highly effective in maintaining a eCTD project.

• QC often and early – cheack all hyperlinks and TOC to ensure they are working well
• Ensure all people involved are using the same software version and they are kept up to date
• Legacy documents need to be converted into a searchable format, scan with OCR or re-type
• Use the online submission tools for regulatory bodies

As consultants working in the area of drug development, regulatory strategy and development strategy we are often involved in these kinds of document development processes and good housekeeping is vital. eCTD is coming to us all so its best we get up to speed as early as possible.

If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com