The world as we know it is becoming more automated and regulatory submissions are no exception.
Due to the incredible volume of information presented in a new drug marketing application, regulatory agencies are encouraging applicants to submit applications electronically in required formats that can better facilitate their regulatory review.
As agencies increase the pressure on organizations submitting electronically, we've seen the rise of a common standard to submit market applications in the Electronic Common Technical Document (eCTD) format.
The ICH's eCTD format allows for the electronic submission of the Common Technical Document (CTD) from the applicant to the regulator. While the table of contents is consistent with the harmonized CTD, the eCTD also provides a harmonized technical solution to implementing the CTD electronically.
As the use of eCTD has grown across the globe and with the upcoming deadlines for electronic submission looming, we wanted to give you a visual explanation for the rise of the eCTD standard, and shed some light on what's to come.
Comment below what has most surprised you the most about the growth of eCTD or perhaps where you can see its development going in the future. Please feel free to share this infographic with your colleagues!
QUIZ: How Much Do You Know About Regulatory Submissions?
How to Reduce Time and Cost When Implementing an EDMS
10 Benefits of Moving to an Electronic Document Management System (EDMS)
5 Reasons Why You Should be Attending DIA's Clinical & Regulatory Operational Excellence Forum
Software Vendor Selection: Requesting Proposals & Quotes
9 Key Attributes of a Cloud-Based EDMS in the Life Sciences
How to Successfully Prepare for the Upcoming FDA eCTD Deadlines
Software Vendor Selection: How to Define Your Requirements
How to Write a Powerful Business Case for Implementing an EDMS
Software Vendor Selection: The Pitfalls and Successes of Vendor Demos