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Archive for the ‘ANDA’ Category
Top FDA Processing Issues with eCTD: A Recent Update
posted by Kathie Clark @ 8:15 AM
Wednesday, May 19, 2010
At a GPhA/FDA Labeling Workshop on April 14, 2010, Virginia Ventura of CDER’s Office of Business Informatics presented CDER Update eCTD & Gateway Submissions. Along with lots of other useful information, Ms. Ventura provided an assessment of the current Top Processing Issues with Esubs:
|
Description |
Percent of total |
|
Unable to extract info from PDF form (sponsor did not use fillable form) |
52% |
|
Missing form (356h, 1571 or 2252) |
13% |
|
Bad Characters (per eCTD Spec) in file or folder names |
10% |
|
Duplicate sequence (sponsor sent twice) |
10% |
|
“High” validation errors |
7% |
|
Media empty or corrupted |
4% |
|
Wrong application number in us-regional.xml |
2% |
|
Invalid submission type identified (eCTD submitted as non-eCTD or vice versa) |
1% |
|
Valid application number with incorrect type (combination is valid but not Sponsor’s application) |
1% |
Certainly, the high percentage of submissions not using fillable forms is startling – Ms. Ventura mentioned that most of these are ANDAs. She spells out the solution for using 356h fillable forms (including their correct use with annual reports) – consult the presentation for details. She also stresses that the correct use of fillable forms results in your submission getting to the reviewer much quicker (best case an amazing 10 minutes!).
The amount of High Severity validation errors is also concerning, as the presentation reiterates what the FDA has said before - High Errors = Submission cannot be accepted. Therefore, up to 7% of these submissions may have been rejected, resulting in time off the PDUFA clock in many cases.
All of this serves as a wake-up call that validation and submission QC are more important than ever. Be sure to read the presentation for more tips on STFs, QC of us-regional.xml, use of the gateway, and many other quality issues and considerations.
(1 Comment )
This year’s DIA annual meeting was more of a checkpoint rather than revealing startling new information – at least in the eSubmissions area. However, a lot of interesting information was exchanged. Today, I’ll focus on the FDA’s presentations. I’ll follow up later with information from other authorities and industry.
Gary Gensinger provided his usual update on eSubmissions at the FDA:
· In the CDER town hall meeting, Gary noted that FDA is looking at drafting legislation to require eCTD – however, this is a lengthy process and no target date is being released at this point.
· As of shortly before the meeting, FDA had received a total of 6015 applications consisting of 72154 sequences. FDA expects to receive in excess of 4500 eCTD sequences in July of 2009.
· There are some interesting trends by application type:
o 52% of NDAs received are now fully electronic.
o ANDAs have grown by 70% since November 2008 – a huge uptick. If you’re in the generics industry and still submitting on paper, you are behind the curve.
o While only 12% of INDs are submitted electronically (up by 1% since last year), 28% of IND Amendments are submitted electronically – a result of maintaining an ever larger number of INDs submitted electronically to date. (By the way, I had an FDA reviewer who stopped by my booth mention that he cringes when presented with a paper IND these days…)
o An impressive 83% of Efficacy supplements are electronic, up by 12%
o CMC supplements are holding flat at 47% electronic
· FDA is working on an agency level receipt date guidance (the current document applies only to currently only CBER/CDER)
· Gary reminded sponsors that briefing packages must still be submitted in paper even if they are also submitted as an eCTD sequence.
Mark Gray gave an overview of RPS, and stated that RPS will be in production use at FDA by September 2011. Mark and Gary mentioned that ICH will not be making any significant updates to the eCTD spec – there will be no DTD changes as ICH and the regulators look towards moving to RPS as “eCTD Next Major Version”.
On June 11th, 2008, FDA issued a Revision 2 of “Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” (http://www.fda.gov/cder/guidance/7087rev2.pdf). The previous version, Revision 1, dated from April 2006.
So what’s new? Very little.
The updates are all administrative in nature, and basically consist of:
- Revisions to title page for FDA’s new address
- Minor revisions in language to remove references to hybrid submissions and eNDAs, which are no longer accepted without a waiver
- Updated reference to ICSR guidance in the Periodic safety update reports section
The latter update is merely the replacement of the previous text:
“You should provide bookmarks for each of the sections and subsections of this report. ICSR and ICSR attachments should be provided as described in the guidance for industry Providing Regulatory Submissions in Electronic Format — Postmarketing Periodic Adverse Drug Experience Reports. ”
with:
“ICSR and ICSR attachments should be provided as described in FDA’s guidance for industry on electronic submission of postmarketing ICSRs (Available under the topic “Electronic Submission” on CDER and CBER’s guidance Web pages).”
One anticipated change that did not appear in this document was the decrease of the maximum recommended path length. ICH/FDA guidance currently states that the path length can be up to 230 characters. However, for those using the gateway to submit, the gateway adds characters to the path. FDA said at DIA in June that they recommend limiting the path to 150 characters, and reminded the audience that FDA reviewers do not see the folder names so their significance in the US is minimal. Path length problems can result in documents not being seen in the agency’s viewer because it is not given all of the necessary information.
ANDA Checklist
Another fairly recent CTD/eCTD related update was the revision of the ANDA checklist on May 28th. (the previous version was dated October 17, 2007). It is posted as PDF (http://www.fda.gov/cder/ogd/anda_checklist.pdf) and MS Word (http://www.fda.gov/cder/ogd/anda_checklist.doc). The Word version is more useful as the PDF is not a fillable form. Changes here include:
- Addition of the Model Bioequivalence Data Summary Tables in 2.7
- Removal of the requirement for MS Word for 5.2 Tabular Listing of Clinical Studies
This brings up a topic that not everyone is aware of - the OGD wants MS Word versions submitted for the QOS and Clinical Summary (Bioequivalence). In presentations, their reviewers have also said that they prefer the QOS submitted as a single document, rather than in modular components.