Educational Webinar Recap: Preparing for the eCTD Mandate
The FDA is planning to mandate electronic submissions in 2014. Since most large pharmaceutical and biotech companies already submit electronically, the greatest impact will be to the smaller companies that do not have substantial IT infrastructure in place and lack the resources of their larger peers.
Jason Rock, Chief Technical Officer at GlobalSubmit, offered greater insight into this topic during a free educational webinar, “Preparing for the eCTD Mandate”, on Wednesday, February 27th at 12:00 p.m. EST.
During this discussion, Jason discussed the implications that PDUFA V will have on regulatory submissions, in particular the mandate to convert all regulatory submissions to eCTD.
We received some great questions during the webinar, and have provided these questions and answers below.
Q: Is it mandatory to put all strength in the same 32P, or can we make one 32P for each? But files are common for all strengths?
A: No. Attributes like drug product are not stored in any system for analysis purposes (e.g. show me all documents for this drug product). Attributes are only used for organization. You should look at your submission, and determine the best organization. It is not a good idea to repeat content where it does not need to be repeated.
Q: How can I manage broken links during the lifecycle?
A: You can always replace a document if you have broken hyperlinks. I would consider that a reviewer will re-review a document if you submit it again. If the document only has one broken hyperlink, then I would not resubmit that content.
Q: Can you tell us about PDF 1.7 and below, or PDF 1.4 & 1.7?
A: The agencies are asking for PDF 1.4 to 1.7. Since the PDF standard is always additive, PDF 1.1 is fully compliant to PDF 1.7 (or PDF 1.2 and above).
Q: For replace and delete operations, when the leaf IDs don’t match, will the FDA still be able to accept and review?
A: Yes. You should think about resubmitting the leaf if the history is really important.
Q: What is the typical cost of software?
A: Every vendor charges a different amount for different parts of the product. The number of submissions and users you have will also impact pricing. If you are interested in learning more about GlobalSubmit, please contact firstname.lastname@example.org.
Q: Should PDF be text-based meaning “OCR”?
A: Yes, wherever possible.
Q: What is the main difference between eCTD and RPS?
A: eCTD is version 3.0 and RPS is version 4.0, so it’s essentially just a new version. The big difference is that RPS is an open standard, while eCTD is closed.
Q: If a sequence number exceeds 9999, what will be the next step?
A:The next version of eCTD will have 6 digits. Right now, no submission is close to going over 9999.
Q: What are STFs? Can you provide a snapshot of one?
A: STFs are study tagging files. STFs extend the eCTD to add extra sections like protocol, study body, etc.
Q:What aspects of the eCTD process can a typical vendor usually handle?
A: Vendors can pull your documents together, reformat them, and create an eCTD XML file for you. For more information on GlobalSubmit, contact us at email@example.com.
Q: The way I understand STFs is that a tag is needed for the protocol, and a tag for the report. Are separate tags needed for each component of the low level granularity report?
Q: What about DMF submissions? Is there also a plan to have eCTD mandatory? If yes, when?
A: DMF submissions will eventually be mandatory. The guidance for these submissions is currently being worked out.
Q: Will promotional submissions to OPDP most likely be required in eCTD by the end of 2014 Q1?
Q: Will we be able to change incorrect metadata with future versions of eCTD?
A: Yes, you should be able to change metadata in future versions (i.e. eCTD version 4).
Q: Is it cheaper to outsource publishing then have it in-house?
A: It depends. There are a lot of factors that go into the pricing of software and services. If you are interested in learning more about GlobalSubmit, please contact us at firstname.lastname@example.org.
Q: Can publishers submit to the FDA gateway if I am located in India?
A: Yes, you can submit to the gateway from anywhere in the world.
Q: What is meant by publishing? Please clarify since this is not publishing to paper.
A: Publishing means eCTD assembling.
Q: As a follow-up, what is the most effective way of training employees to enable us to bring eCTD publishing in-house?
A: I recommend a training program, get a trainer, go to classes. The RAPs classes are a good place to start. Then for first submission, you should also get a contractor to help you through the process. There are a lot of unknowns that you will want to have an expert to help guide you through them.
Q: What criteria should a company consider in choosing an eCTD publishing software?
A: It is important to consider the vendor’s experience, the number of submissions completed, the relationships that vendor has with regulatory agencies. Other key criteria are the quality checking processes.
Q: Is eCTD required for academic institutions that have sponsor-investigator INDs? IDEs?
A: Most academic institutions will be exempt, depending on the size of the submission. Single investigator studies will be exempt.
Q: You mentioned the available set of validation criteria. However, how do you find those high/low errors?
A: In my presentation, I provide a link to the FDA website. For more details visit: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm
Q: What is the purpose of the us-regional.xml file?
A: This is essentially just another XML file. This is where the application, sequence number, and sequence type goes. This file is not harmonized, so each region has their own standard. This will also go away with RPS.
Q: What about legacy CSRs?
A: You should not need to reconvert legacy documents; a scanned version of the document should be fine.
Click here for a copy of the presentation slides.