Notes from RAPS Advanced eCTD Workshop

This week’s blog posting is from Rahul Mistry, CEO of GlobalSubmit, who recently was a featured speaker at the RAPS workshop entitled “Advance eCTD Submissions”.  Rahul’s presentation focused on eCTD quality, a topic that obviously interested the audience based on the significant number of questions that he received. Two weeks ago I had the pleasure at presenting at an Advanced eCTD Workshop hosted by RAPS in...

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Progress for Health Canada’s Electronic Review Program

Well,it’s back to business after the holiday break. As promised, here’s my update on what’s happening at Health Canada. At the recent DIA eSubmissions conference, Health Canada’s Vianney Caron presented an update on eCTD at Health Canada. The E-Review Program The purpose of Health Canada’s E-Review program is to support branch business processes throughout the health product life cycle across product lines using an...

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FDA to Reject eCTDs with Significant Technical Issues

Due to the increased adoption of the eCTD and number of submissions received by the U.S. FDA, submission quality is receiving increased focus and attention at the U.S. FDA. In recent conversations with FDA officials, they have expressed a commitment to increase their diligence and oversight with respect to submission quality and have signaled their intention to begin rejecting eCTD sequences having significant technical issues....

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Japan Reports Progress in eCTD Submissions

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...

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