As the standard format of submitting regulatory information to health authorities, an eCTD or electronic common technical document is essential for all organisations within the pharmaceutical industry. Used worldwide for the submission of applications, supplements and reports, an eCTD ensures all bases are covered using a carefully defined structure and associated cross-links to supply supporting information.
With this, there are many advantages to using eCTD submissions when compared to more traditional methods. In addition to being the standard format used by many major health authorities, eCTD submission promises ease and efficiency in an otherwise complex process without the need for scanning, copying or storing paper documents.
Updating an eCTD is also simple with changes able to be undertaken and identified at the touch of a button, access possible simultaneously, and product lifecycle tracking made possible. Reading and updating eCTDs has been made simpler with the use of eCTD viewers, but what is an eCTD viewer and how can your organisation benefit from using one?
An introduction to the eCTD viewer
In short, an eCTD viewer enables organisations to review the regulatory documents an eCTD contains with ease, speed and convenience. Specifically developed with eCTDs in mind, a viewer helps organisations to make sense of the complicated, synonymously difficult-to-read hierarchy that goes hand-in-hand with eCTD submission.
How eCTD viewers can be used by your organisation
There are several eCTD viewers currently available, which enable the import of dossiers for full application and individual submission. Most viewers provide a personalised setup for the easy navigation of the CTD structure, with some even allowing you to compare data across multiple submissions.
The use of eCTD viewers offers the ease of use and peace of mind organisations need to make key time and resource savings. eCTD viewers facilitate reduced review times, quicker response times when working with an agency, and faster approval rates overall. They also unlock further advantages in terms of compliance as ShareVault details:
“The eCTD viewer you choose ought to be compliant with the latest eCTD specifications as well as be backwards-compatible with previous specifications from ICH and Canadian, E.U., Japanese, Swiss, Taiwanese and U.S. regions. You should be able to view any eCTD submissions, even those produced by other software vendors’ publishing tools, through your eCTD viewer, as long as they conform to ICH and regional eCTD specifications.”
ONIX – the link between you and your eCTD submissions
Making your eCTD submissions quick, compliant, and easy to navigate and view doesn’t just come down to your choice of eCTD viewer. By collaborating with us, you can have access to the knowledge and support you need to negotiate the ever-changing, complex regulatory environment.
With a 100% eCTD technical approval rate, your eCTD submissions will certainly be in the right hands. Our global team has worked with clients around the world and regulatory health authorities serving countless countries - including the FDA, Europe (EMA, MHRA and National Agencies), SwissMedic, Health Canada, and TGA - to submit eCTDs on time, every time.
For further information regarding our eCTD submission management and regulatory advisory services, please contact us today.