ICH Working Group Making Progress on Next Major Version of eCTD

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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.


Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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