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Archive for the ‘Regulated Product Submissions (RPS)’ Category

DIA EDM and ERS/eCTD Conference Recap

posted by Emily Onkka @ 1:46 PM
Thursday, October 18, 2012

Today’s entry was provided by Emily Onkka, Director of Project Management and Regulatory Operations at GlobalSubmit and new regular contributor to Based in San Diego, CA, she will be leading GlobalSubmit’s professional eCTD services, including eCTD compilation, ESG transmission, publishing, quality checking, and best practice implementation. Prior to joining GlobalSubmit, Ms. Onkka was Head of Regulatory Operations at Ardea Biosciences, Inc.

This year, DIA combined two conferences joining the electronic data management (EDM) and electronic regulatory submission (ERS)/eCTD into one event. The conference provided three tracks split into content generation, content management, and electronic submission focus areas. There were also several collaborative sessions that allowed meeting attendees to share ideas and best practices for managing the content continuum from authoring to submission delivery and maintenance. The meeting was well attended both by FDA and industry alike; allowing sponsors access to first-hand updates from the FDA speakers on electronic submission initiatives.

FDA speakers communicated that the Agency will likely begin accepting eCTD Version 3.2.2 in early 2014. Sponsors will not be required to upgrade to eCTD Version 3.2.2; however, once a sponsor starts submitting in eCTD Version 3.2.2, they cannot revert to the old format. With regard to RPS, although eCTD Version 4 is still in testing at ICH, the FDA continues to convey their commitment to implementing the standard and begin accepting it potentially as early as 2015. All of the new functionality in eCTD Version 3.2.2 will be part of eCTD Version 4. Therefore, although the two new versions seem to have relatively close implementation dates, the effort sponsors will go through to update internal business processes that will support the implementation of eCTD Version 3.2.2 will not be lost when implementing eCTD Version 4 (RPS) a year or so later.

As in years past, the conference continues to provide practical and relevant information to attendees. One final note, be sure to also check the FDA Forms Page for new versions of forms 1571 and 356h that were released on October 1, 2012.

Presentation Details:
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, will provide 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 will provide 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.

Top 3 Learning Objectives:
1. Why eCTD v4 was developed
2. What the agency’s plan is for eCTD v4
3. What’s the difference between eCTD v4 and eCTD v3

Presenting Expert:
Jason Rock, CTO at GlobalSubmit

Click here to Register

PDUFA V and the Impact on You

posted by Jason Rock @ 3:08 PM
Tuesday, March 20, 2012

In September, the FDA issued its Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017.

There are many proposed improvements related to the FDA review procedures, including a mandate of the eCTD. This mandate will start 24-months after publication of the corresponding final guidance for marketing applications and 36-months after publication of the final guidance for commercial INDs and amendments.

The final guidance will be released no later than 12 months from the close of a public consultation period on the draft guidance. The corresponding draft guidance will be issued by December 31, 2012 at the very latest. The initial guidance will reference eCTD version 3.2.2; however, the final guidance might refer to a different standard, namely RPS, if the FDA determines the new standard is more efficient and effective. The FDA also mentions that they “shall also accept submissions using the previous version for no less than twenty-four (24) months.”

Although many of the goals for priority and standard NDA and BLA review (including Class 1 and Class 2 resubmissions, efficacy supplements, and manufacturing supplements) remain the same as under PDUFA IV, the proposed PDUFA V agreement establishes a new review model that will apply to all New Molecular Entity (“NME”) NDAs and original BLAs received from October 1, 2012 through September 30, 2017, including applications that are resubmitted following a refuse-to-file action.

The new program includes a pre-submission meeting, a mid-cycle communication, and a late-cycle meeting at which the FDA review team and the applicant will discuss the status of the review of the application. At the pre-submission meeting, the FDA and the applicant will agree on the content of a complete application for the proposed indication(s), and the applicant may also reach agreement on submission of a limited number of application components.

Another important change is the treatment of “major amendments” to pending applications.

Under PDUFA IV (and FDA’s regulations at 21 C.F.R. § 314.60), “[a] major amendment to an original application, efficacy supplement, or resubmission of any of these applications, submitted within three months of a goal date, may extend the goal date by three months. A major amendment to a manufacturing supplement submitted within two months of the goal date extends the goal date by two months” (emphasis added). Under the proposed PDUFA V agreement, however, “[a] major amendment to an original application, efficacy supplement, or resubmission of any of these applications, submitted at any time during the review cycle, may extend the goal date by three months”, and “[a] major amendment to a manufacturing supplement submitted at any time during the review cycle may extend the goal date by two months.”

The Latest on Regulated Product Submission (RPS)

posted by Jason Rock @ 2:26 PM
Monday, June 6, 2011

It has been a while since I have updated you on the RPS project. Back in September, I had expressed cautious optimism on being able to bring RPS to vote (ballot) in May 2011. We did not make the May 2011 ballot, thus the ballot is now delayed until September 2011.

We did not make the ballot, in my opinion, since we are still working on refining all of the requirements. We have two requirements left to be finalized; namely, being able to reuse studies and all of the components in two applications and support for the new European variation legislation.

Being able to reuse studies and all of the components in two applications will allow sponsors to create a study, define all of the components (e.g. protocol, study report body, synopsis, etc) in one application (e.g. investigational application) and refer to the study in your marketing application. This benefits sponsors since it allows them to synchronize content for a study in more than one application.

The new European variation allows a sponsor to create one sequence (e.g. a manufacturing change) and apply that sequence to many products. This will benefit sponsors since they will no longer have to track multiple products for one manufacturing change.

To create the publication before the ballot opens, HL7 headquarters needs content over a month in advance. The ballot period is one month: see the following sample HL7 publishing schedule.

  • 5 weeks before publication: Initial Content Due – Submissions should be as complete as possible, particularly for a first-time ballot. In all cases, the submission should indicate the topics and artifacts that will be included in the forthcoming ballot. If possible, complete preview material should be submitted so that it can be made available on the Ballot Preview site by the end of this week.
  • 4 weeks before publication: Ballot Preview – All content to be included in the preview site is due. The Ballot Preview site (based on the previous ballot) will go live.
  • 3 weeks before publication: Reconciliation, Complete & Supporting Content Deadlines – All previous ballot reconciliations for normative ballots must be completed and appropriately captured on the ballot website.
  • 2 weeks before publication: Final Content Due – All final corrective changes to existing content are required.
  • 1 week before publication: Provisional Ballot Opening – This is the earliest date that the ballot site can open and be announced to the membership. In any event, the ballot must open before the end of this week. 

I feel confident that we will make the September 2011 ballot. Stay tuned for more information.

A number of good articles related to eSubmissions have been posted online recently.  Below, a recap based on posts from my twitter account,  

In Standards news:

Finally, a few upcoming conferences have been announced:


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