Q&A Regulated Product Submissions (RPS)

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The FDA is looking to mandate electronic submissions in the next few years. At the same time, they and other regulators are looking to upgrade the eCTD standard. Why would the FDA mandate electronic submissions and change the standard at the same time?

Jason Rock, Chief Technical Officer at GlobalSubmit, offered greater insight into this topic during a free educational webinar jointly hosted by Cato Research and GlobalSubmit, “Background and Drivers to the eCTD Next Major Version / Regulated Product Submission”, on Thursday, October 4th at 1:00 p.m. EDT.

During this discussion, Jason provided detailed reasons why a new standard was created, the timelines when the standard will be complete, what each of the agency’s plans are, and the major differences between eCTD version 3 and 4.

We received some great questions during the webinar, and have provided these questions and answers below.

Q: If the MAH moves to RPS and edits an attribute within M3, for example, and the competent authority stays in eCTD, won’t structural problems occur upon uploading on the agency side?
A: It should not cause a problem. One of the goals of RPS was to be able to move from eCTD to RPS in a review cycle. I believe that we can meet that goal.

Q: Now that we have Module 1 template in the draft format in FDA website and given that it will be finalized in the year 2013, when can it can be updated?
A: Iā€™m expecting FDA to implement the new Module 1 in January 2014.

Q: Are there concerns that the numbering flexibility will allow non-ICH countries to develop their own numbering systems?
A: Non-ICH countries can create their own numbering system. There were discussions a while back to update the numbering system in ICH.

Q: How do you envision the two way communication to work? Do I submit sequence 0000 and FDA responds with sequence 0001?
A: RPS and eCTD have different identifiers. The identifier for the eCTD is the sequence number (e.g. 0000). The identifier for RPS is more like the identifier for SPL (e.g. 127952E9-C783-4202-9AD1-D920A01E18A0). RPS has a sequence number that specifies the order of the sequence compared to other sequences. This sequence number in RPS is not guaranteed to be unique. Accordingly, the sponsor and FDA will not have the same submission identifier, but they can share the same sequence number.

Q: It was mentioned that unique IDs will be used in document hyperlinking. Does this mean that cross-document links can only be created/reviewed within RPS publishing tools?<br />
A: Unique IDs will be used for the documents inside of RPS, but not for cross document hyperlinks inside of Adobe. No special tools will be needed to see the cross- document links.

Q: Is the FDA planning to use DUNS numbers for the Universal Facility Identifier (UFI) or a new unique number?
A: That is the current thought.

Q: Why do the M1 now and not wait for full eCTD4?
A: FDA would like to align with ICH and upgrade some of the functionality now. ICH will most likely not approve RPS until 2014.

Q: Given the very structural changes in formats/standards – how do I migrate existing eCTD databases to RPS without losing the lifecycle functionality?
A: Hopefully your vendor will take care of this for you when tools are upgraded.

Q: When will a visual example of an RPS submission be widely available?
A: There are many examples ā€“ some with screen shots ā€“ for RPS at http://wiki.hl7.org/index.php?title=Regulated_Product_Submissions.

Q: Is the submission effective date the same as the approval date?
A: No, the supplement effective date is Prior Approval Supplement (PAS), Changes Being Effected-0 (CBE-0), Changes Being Effected-30 (CBE-30)

Q: Seems like constructing validation rules for a flat structure will be a challenge.
A: In fact, it is easier to create validation rules on RPS since RPS is more closely aligned to how systems understand information.

Q: What about use of IDMP standards in the RPS for product ID?
A: The information about IDMP can be submitted inside of RPS. IDMP defines product information to more granular levels than needed for RPS.

Q: What about migration of current eCTD sequences to RPS?
A: Hopefully your vendor will take care of this for you when tools are upgraded.

Q: What happens to a legacy eCTD (i.e. an IND) when RPS is implemented?
A: Hopefully your vendor will take care of this for you when tools are upgraded.

Q: If a flat file list is utilized in RPS, how are files like AE.XPT from multiple studies be placed at the same location?
A: RPS does not define a definitive file folder structure, you can create any folder structure you like. There will be guidance provided to how to structure your folders.

Q: Is FDA still planning on implementing two-way communication when they implement RPS either in 2014 or 2015, or introduce it at a later phase?
A: The current plan is to implement two-way communication with RPS.

Click here for a copy of the presentation slides.

Author: GS

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