Electronic Common Technical Document - eCTD

What does it really mean?

The eCTD (electronic Common Technical Document) is an industry to agency interface, facilitating the transfer of regulatory information from industry to the reviewing agency:

• The eCTD will ease agency review of your product dossier and offer significant benefits with a shorter time to market.
• The eCTD is a living document that is designed to evolve throughout the life cycle of your product and will always reflect the regulatory changes made to your product.
• The eCTD will help you with regulatory compliance because it is always current with all registered and approved data in one place.

Why is it needed?

Pharmaceutical companies have been manually handling huge amounts of paper based documentation for regulatory submissions. Multiple copies of these bulk documents were sent to regulatory authorities for review and archiving leading to problems of data storage. The process was cumbersome and involved significant investments of time, money and effort. The whole process was repeated when reviews and modifications happen throughout the development lifecycle. Both industry and regulators recognised the need for standardising the documentation process and automating submissions was great. The eCTD is the solution to these issues.

The eCTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is an international standard for document submission that is currently recognised by regulatory agencies across the EU, USA and Japan. Organisations have begun moving towards eCTD implementation, thanks at least in part to eCTD’s extended benefit of development lifecycle management.

There is no difference between CTD and eCTD in terms of scientific, technical and clinical content. However, there are regional differences in the eCTD implementation between ICH regions. At CambReg we keep up to date with regional changes, so you can be sure your electronic submission will be in line with current local requirements.

Are you ready for eCTD?

There are two routes your company can take:

• Purchase eCTD software and develop your own in-house solutions or
• Let CambReg handle all your electronic publishing needs.

Get set...

It is important to balance the high cost of eCTD software, extensive staff training and IT support with the seamless service CambReg can offer.

Go!

There are several dates you need to be aware of:

EU:

• Since 1 July 2008, the EMEA has accepted eCTD submissions without the need to submit paper copies.
• After 31 December 2008, CHMP members will be encouraged not to demand paper copies. Please follow the link to the EMEA website for more details.
• 31 December 2009, is the deadline for the EU national authorities to accept eCTD without paper copies.
• 01 January 2010 is the date after which all centralised applications must be submited in eCTD format.

US:

• FDA requires all electronic sunmissions in eCTD by end of 2007 (paper submissions still possible).

Be a Winner!!

The eCTD will save on duplication time, shipping costs and archiving as well as offering advantages with navigation and review. The eCTD is fully bookmarked and hyperlinked and can manage the life cycle regulatory documentation of your product.
We are happy to convert your legacy documents in Notice to Applicants (NTA) format or paper CTD to eCTD and electronically publish your MAAs for submission to your chosen Health Authorities in the EU. We can also convert legacy MDA documents to eCTD for FDA submission.

Please contact us if you wish to discuss your eCTD compliance in more detail.