Module 1 Changes Scheduled for Spring 2012

The draft version of the US eCTD Module 1 was completed in June 2011, and appeared on the Federal Register (FR) docket on October 26, 2011. This draft contains major changes, and can be found here. As is typical with FR notifications of this nature, public comments can be made for 60 days after appearing on the docket, meaning that comments were able to be submitted up until December 27, 2011. The public comments and internal FDA change requests will be reviewed and analyzed to determine whether any modifications are necessary to the draft.

The FDA response to comments received is expected in the beginning of April 2012. This timeline allows interested parties to review the comments 30 days prior to the May 7, 2012 public meeting. This public meeting is largely for vendors to clarify the changes vendors must implement to meet the new requirements. The final Module 1 and related documents are expected during the second quarter of 2012.

After the specification is finalized, the FDA validation and reviewing system provided by GlobalSubmit will be enhanced to meet the new requirements. The time frame of implementation of a new validating and reviewing system is planned for the beginning of 2013. Once in production, the FDA will accept submissions using the new Module 1, including Office of Prescription Drug Promotion (OPDP) – formerly known as the Division of Drug Marketing, Advertising and Communication, or DDMAC – information in eCTD format. 

1st Quarter 2012

In This Issue:

The State of FDA Implementation 

The FDA has performed extensive testing on the load performance, validation criteria, usability of validation reports, and updates to how the submission is sorted in GlobalSubmit REVIEW.

The FDA is a unique client, as it has over 4,000 users and over 200,000 sequences. The FDA looks at validation reports to determine if the sequence is reviewable and helps sponsors create higher quality sequences.

Due to the aforementioned as well as the increased adoption of electronic submissions, the FDA needs the following:

• Ability to load several thousand sequences a day (current workload is 600 sequences a day)
• Ability to load 200,000 sequences in two weeks
• Prioritize which sequences are loaded first (load priority reviews first)
• Analyze validation reports with different views
• Have a log of every sequence that received a technical rejection

GlobalSubmit's Submission Suite provides all of the above criteria to the FDA. The last hurdle on rolling out GlobalSubmit 2010 is updating the validation reports. Last quarter, GlobalSubmit and the FDA worked on making the validation reports friendlier. We have since finalized these reports, and hope to keep on schedule for an April install at the FDA.

Wishing You and Yours a Happy New Year!

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PDUFA V and the Impact on You

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.”

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