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Archive for June, 2009
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”.
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Last week I was at the ICH meeting in Japan. If you haven’t been to Japan, I highly recommend a visit to this beautiful country and its very friendly people.
We had a productive meeting. My time was split between working on eCTD and ICSR. The eCTD group focused on change requests and requirements for the next major version. While there were no significant changes made, we are working hard to include Module 3 Q&A as soon as possible. The change request will be posted to the ICH website in the near future.
One of the things the group focused on was reviewing which PDF version can be accepted by all parties. There were no changes to the PDF 1.4 recommendation, but all parties agreed to determine the feasibility of endorsing the ISO32000 PDF version soon. That said, it’s a very real possibility that ISO32000 PDF will be endorsed at the October 2009 meeting. We are also looking at using XML as a replacement for PDF. Do not expect that change any time soon.
The group also made tremendous progress in determining ICH requirements for the next major version of eCTD. Since we did not complete said requirements however, I would fully expect that ICH will officially participate in the RPS standard after the October 2009 meeting.
In the margins of the meeting – meaning at the hotel bar –differences between US and European submission were discussed. I learned, for instance, that original marketing applications in the US are typically five to 10 times larger in page count and file size than European submissions. I also found out that there is a 10+ multiple in the number of amendments found in the average US submissions when compared to a similar European submission. In fact, one sponsor said that a drug approved in Europe had four sequences, while the same drug in the US had 78 sequences. Now that’s something to think about.
Look for me at the DIA Annual Meeting /eCTD Related Presentations
posted by Kathie Clark @ 5:27 PM
Monday, June 15, 2009
The DIA Annual Meeting will be held in San Diego June 20-25. If you are attending and we haven’t met yet, I’d love to meet you! Look for me in our booth, 923 (get your badge scanned to enter a drawing for our extremely cool giveaway - I’m not going to reveal what it is). I’ll be joined in the booth by my collegues and well-known industry experts Jason Rock and Rahul Mistry.
I’ll also be in some of the eCTD-related sessions, which include:
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International eCTDs: An Update on Regulatory Authority Experience
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Authoring CTD/eCTD Submissions: Updates and Case Studies
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FDA Data Standards Initiatives (Featuring GlobalSubmit’s CTO, Jason Rock)
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Convergence of Data and Document Standards: Where Does CDISC Meet eCTD?
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Pursuing Standards to Enhance eCTD Deliverables: Pharmaceutical and Research Manufacturer Association Electronic Regulatory Submissions (PhRMA ERS) Group Annual Update
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Global Submission Management: Challenges and Opportunities
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Standards Shock Therapy: Monitoring the State of CDISC and HL7 for Clinical Research and Regulatory Submissions (Featuring GlobalSubmit’s CTO, Jason Rock)
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IND to CTD in Electronic Format: Strategic Considerations for Life-cycle Maintenance
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Annual CDER eSubmission Update: The Technical Side
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Life-cycle Management: Where the Real Challenges Are – Module 3, IND and NDA
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International eCTDs: An Update on Regulatory Authority Experience
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Authoring CTD/eCTD Submissions: Updates and Case Studies
I’ll be commenting on the presentations on this blog in late June or early July.
SwissMedic has added new information to its website on their plan for accepting eCTDs. Some key points:
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Swissmedic intends to accept authorisation applications in the eCTD format, i.e. in electronic form and with no paper documentation. In doing so, Swissmedic aligns itself with the EMEA road map for implementing eSubmissions in the EU Member States (Centralised procedure). Electronic submissions are to be accepted in eCTD format only as of 2010. The implementation of applications is to be accepted in eCTD Format only as of 2010.
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In order to conform to the tight schedule of the introduction of eCTD by January 2010, Swissmedic needs to restrict the range of technical options, specifications and guidelines accordingly. Possible extensions to the project (such as electronic signatures, an online portal or long-term archiving) will be developed later.
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Swissmedic is looking for companies that are willing to submit an electronic version in eCTD format (Modules 1-5), in addition to a paper submission, during the period from 1 June to 31 August 2009. See the announcement for details.
Guidance Documents are not yet available, but will be produced on the following plan:
Information on the eSubmissions business process
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A Questions and Answer Document to handle the issues that arise most frequently (publication in July 2009)
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Guidance for Industry on Providing Regulatory Information in eCTD Format (publication October 2009)
Information on specifications for the eCTD format for eSubmissions
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The Swiss Module 1 specifications for eCTD (publication October 2009)
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Swiss eCTD Validation Criteria (Publication October 2009)
Implementing eSubmissions within the SIMES project includes the following milestones:
Milestone 1: as of March 2009: publication of project information on the Swissmedic website
Milestone 2: July 2009: first version of the eCTD specifications and Swissmedic practical guidelines ready for feedback and review.
Milestone 3: October 2009: revised eCTD specifications and practical guidelines are released.
Milestone 4: January 2010: going live. Submissions in eCTD format authorised for certain types of applications.
Milestone 5: March 2010: follow-up evaluation and adjustments.
You can also find contacts for additional information on the website.
Warning: Some HAs not accepting PDFs other than 1.4
posted by Kathie Clark @ 2:19 AM
Thursday, June 4, 2009
Recently, some sponsors have been reporting the rejection of eCTD sequences or NeeS containing PDFs of any version other than 1.4.
The Swedish agency Medical Products Agency (MPA) states on their website on the page Electronic submissions to the MPA “The MPA will check eCTDs against the A criteria listed in the “EU eCTD Validation Criteria” v.2.0 (see link to the right), and also check for the B criteria that the eCTD has PDF files in format PDF 1.4 only (very important for archiving).” Some sponsors have reported that MPA is actually rejecting eSubmissions containing PDFs other than version 1.4, even though (as noted) this is only a “B” error in Europe (see Error 37 in EU eCTD Validation Criteria V2.1). The definition of “B” Priority is “accept but may request corrections (fix with a subsequent sequence)”.
The French authority Agence Française de Sécurité Sanitaire des Produits de Santé has also been reported to be refusing submissions containing PDFs other than 1.4, but I could not find anything on their web site to support this except a mention in NOTICE TO APPLICANTS FOR MARKETING AUTHORISATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE as follows: “The file format for text documents must be PDF 1.4″.
ICH’s guidance on this (in the eCTD 3.2.2 specs) is “All ICH Regional Health Authorities are able to read and have agreed to accept PDF files saved as PDF version 1.4… Please consult regional guidance to submit other versions of PDF.” FDA of course has a whole document on this topic, Portable Document Format Specifications (note the new location on their re-organized web site). I have heard FDA say in the past that their issue with PDF formats is also archiving, as their reviewers have long since moved past Adobe versions that can only handle version 1.4.
If you are submitting to regional authorities in Europe, you may wish to check with those authorities and also to run your submission through the Belgian Registration file validation. Also keep in mind that one of your biggest issues could be literature references, which may be supplied to you in PDF format. If it’s not possible to “save down” to V1.4, worst case you might have to scan to V1.4.