Since January 2010 eCTD (electronic Common Technical Document) submission has been the mandatory format in Europe for all marketing applications in the centralised procedure. Although implementation in the MRP, DCP and national procedures has yet to be agreed, several Competent Authorities are already highly recommending e-submission applications here, aiming to make the process mandatory across the board in the future.
Changing to this new format requires additional resource, training and investment and many companies have found the cost involved in implementing in-house eCTD publishing prohibitive, however the benefits of eCTD are obvious - simplified document lifecycle management, faster processing times and reduced authority fees all provide clear incentives to the industry and authorities.
eCTD Publishing
At TRAC we can create the eCTD for you and manage the electronic submission. We can create full eCTDs for new applications as well as convert dossiers in part or whole for older Marketing Authorisation Applications (MAAs) and variations. We also offer full support and regulatory guidance throughout the process.
We have worked on a number of dossiers since the electronic format was introduced and our regulatory affairs consultants are extremely proficient in creating, publishing and submitting dossiers in both eCTD and non-eCTD (NeeS) formats.
Download our detailed eCTD document which will help you understand the requirements and assess the benefits of this fast developing new method of submission. If you have any further questions regarding eCTD please Contact Us.
Lisa Pascoe
Regulatory Affairs Executive
Guide: eCTD
This guide, as well as other information can be downloaded from our download centre.
