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Archive for February, 2008
eCTD readiness in Japan has always been more challenging than in other regions due to issues with tools handling Kanji characters among other reasons. However, Kiyohito Nakai,
Priority Review Director at PMDA, was able to report substantial progress in a February 7th presentation at the DIA Doc Management conference in Philadelphia.
Priority Review Director at PMDA, was able to report substantial progress in a February 7th presentation at the DIA Doc Management conference in Philadelphia.
To date, Japan has received a relatively small number of eCTDs. To date, they have received:
- Original Applications: 6, representing 13 sequences
- Reference Applications: 52, representing 70 sequences
Japan also has a new, free eCTD validator - but the catch for many of us is you have to be able to read Japanese…
http://www.pmda.go.jp/ich/m/eCTD/ectd_validator.htm
http://www.pmda.go.jp/ich/m/eCTD/ectd_validator.htm
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ICH M2 (ESTRI) EWG will not implement eCTD 3.3.3
posted by Kathie Clark @ 7:44 PM
Tuesday, February 5, 2008
At the October 2007 ICH Meeting, the decision was taken by the ICH M2 (ESTRI) EWG with approval from the ICH Steering Committee to stop the progression of the eCTD Version 3.3.3 Step 2 for Testing. The reason given was to focus on gathering the business requirements for the next major version of the eCTD.
In general, the changes proposed in Version 3.3.3 were more beneficial to industry that to regulators. The agencies had concerns about the cost and effort of implementing the specification as it was largely focused on incorporating the STF into the eCTD backbone. FDA already considers that they have a satisfactory solution in the STF as it stands, and other regions have not identified any requirements for the STF. Japan in particular was said to be concerned about having to update newly completed procedures and tools to support 3.3.3 in the short term; however, a PMDA representive at the DIA Doc Management meeting expressed “strong support” for eCTD 4.0 during the February 7th International Regulatory Update session.
The M2 EWG also expressed a desire to improve the narrative portion of the specification and address those change requests that can be resolved without changes to the DTD. To the extent possible, existing Q&As will also be incorporated. This revised specification document will be issued as eCTD Version 3.2.1 during the coming months. Version 3.2.1 of the eCTD specification will be accompanied by an updated version of the Study Tagging File (STF) specification, version 2.6.1, which will address improvements to the narrative portion of this specification in the same way but will also not make any changes to the existing STF DTD.
See http://estri.ich.org/eCTD/news.htm for details.