Changing eCTD Submission Requirements: What You Need to Know
Since 2015, the FDA has required certain types of submissions to follow the eCTD format, and has slowly rolled out the requirement to other channels. Even though the deadline for conversion to eCTD for Type III Drug Master Files (DMF) applications has been extended to May 5, 2020, it is still very much in progress, and pharmaceutical professionals must be aware of the constantly changing requirements and evolution of the document format itself.
In the Electronic Common Technical Document (eCTD) Submission Training course, our instructor will not only review the current requirements, but also discuss proposed changes and updates to the format. Common pitfalls will be also be discussed, with clear, workable plans for avoiding the mistakes that lead to delayed responses from the FDA. Our course is a practical workshop with real-life examples of eCTD submissions that pass easily, and those that fail.
Interested course attendees may also be wondering about the FDA’s plan to introduce
Knowledge-aided Assessment & Structured Application (KASA), a system they are developing internally to address the issues with the current eCTD format. Specifically, the eCTD has been criticized because it does not follow the development lifecycle of drugs and devices, and the .pdf format of some of the files allows for unstructured data that delays assessment timelines. In fact, common formatting problems are part of the FDA’s reasoning for delaying the requirements deadline for submitting Type III Drug Master Files (DMF) in eCTD.
To get up to date on eCTD and the potential for implementing KASA, you can register for our course on the course page: Electronic Common Technical Document (eCTD) Submission Training course. The material also covers international and EU regulations, as many foreign regulations require the use of eCTD exclusively. The course runs May 08 - May 09, 2019 Boston, MA. We look forward to seeing you there!
Sources:
https://www.natlawreview.com/article/fda-extends-deadline-ectd-submissions-type-iii-dmfs-to-may-2020
Blog Categories
Stay Informed
