Japan Reports Progress in eCTD Submissions

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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.

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. The catch for many of us is you have to be able to read Japanese.

Author: GS

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