If you thought the differences between US and EU eCTDs were significant, you probably don't want to hear about the differences in the Japanese eCTD. :)
Because the Japanese review agencies rely less on review software, the XML backbone itself acts more as a significant reference for their review. This is a bit of a double-edged sword.
It does allow the sponsor to more accurately predict what the agency sees, although some could argue that this is pretty well known for all eCTD reviewers, anyway.
Because of this, the XML backbone of each sequence is cumulative, not isolated. If you have ever opened up an XML backbone from a US\EU submission and viewed the output, you would see something like this.
Sequence 0000 eCTD DTD version 3.2
- m1-administrative-information-and-prescribing-information
- us-regional [new]
- m2-common-technical-document-summaries
- m2-2-introduction
- New A Sequence 0000 [new]
- New B Sequence 0000 [new]
- New C Sequence 0000 [new]
Sequence 0001 eCTD DTD version 3.2
- m1-administrative-information-and-prescribing-information
- us-regional [new]
- m2-common-technical-document-summaries
- m2-2-introduction
- Delete C Sequence 0001 [delete]
- Append B Sequence 0001 [append]
- Replace A Sequence 0001 [replace]
- New D Sequence 0001 [new]
In Japan however, each sequence automatically points to the documents submitted in previously related sequence. Therefore, instead of each sequence's XML backbone being isolated, it automatically includes previously submitted example. Here's the scenario above, as viewed from a sequence 0001 backbone with the default stylesheet.
Sequence 0001 DTD version 3.2
- m1-administrative-information-and-prescribing-information
- 1. 申請書等行政情報及び添付文書に関する情報 [replace]
- m2-common-technical-document-summaries
- m2-2-introduction
- Replace A Sequence 0001 [replace]
- New B Sequence 0000 [new]
- Append B Sequence 0001 [append]
- Delete C Sequence 0001 [delete]
- New D Sequence 0001 [new]
As this example hopefully illustrates, the Japanese XML will point to all current documents, across sequences.
There are certainly more eCTD differences in Japan, technical, cultural, and lingual. Interested? Leave some comments and I'll share some more if there are enough Japanese eCTD followers out there.
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