How To Prepare for the Upcoming FDA eCTD Deadlines
With technological advancements, the FDA now requires submissions in the electronic eCTD format. Although this seems difficult it could make the process a lot more uniform and easier.
Let's look at what the format is and how to prepare for the eCTD deadline.
What is an eCTD?
The Electronic Common Technical Document (eCTD) is CDER/CBER’s format for regulatory submissions and was designed to increase efficiency in the drug approval process.
The benefits of the eCTD format are as follows -
Easier to organize, categorize and store
Easy to apply and what information
Faster procedure
Minimum costs incurred
Saves time, space and effort
Opportunity to re-use the documents
Promises easy navigation
Using search tools, information is easy to access
Helpful for regulatory life cycle maintenance
No printing or document shipping
Most people who are new to the system and are unsure about the procedures can also make use of the various eCTD publishing services available to make the process easier as they help you format and organize your documents. Failure of this coherent formatting and an understandable structure is what leads to the failure of eCTD applications. However, if you choose to do it yourself here are the details you ought to know to prepare for eCTD-
PDF documents of a defined size range, with legible font and size (usually, Times New Roman or Ariel; size 12) and an acceptable professional margin (one inch) lined through an XML backbone
To follow a said format for the content in the PDF, one can use given templates from Microsoft Word and later convert it accordingly. PDF files that do not follow a substantial acceptable format have also been rejected time and again.
Scan your documents and convert them to a PDF and ensure the content is in high resolution, and it's always better to use hyperlinks to ensure easy navigation through your documents.
Organize your content in one folder. This not only allows for faster work but also ensures that content isn't lost or misplaced in a hurry.
Documents should be searchable
PDF documents should comply with FDA’s “PDF specification” guidelines.
Bookmarks should have inherit zoom settings
Any documents more than 4 pages should contain Table of Contents (TOC) and such TOC should mimic the PDF bookmarks
Study tagging files are requires in Module 4 and 5
Data sets and Data tables are required in the Module 4 and 5
When required PDF document should contain hyperlinks to reference documents
For a successful eCTD submission ensure that your documents follow the above instructions and the requirements stated. The following may help with a successful application-
Stay updated about the new rules and regulations
Plan a year or two before the target submission date to have enough time to organize and regular your submission requirements
Turn to a famous and reliable eCTD publisher to help you focus on producing information and leave the organization, gathering, and managing information to the publisher.
Have a transparent flow and process of information with your publisher to keep a check on the developments over time.
New technological advancements allow better facilitation of applications, not only for you but for the FDA. With such an important challenge ahead, you can either follow the steps required and go for this time sparing procedure or focus on the content and leave the tedious process for your publisher. Either way, there's no debate about the ease that comes with electronic submission.