RPS Working Group Reviews ICH Requirements

The RPS (Regulated Product Submissions) Working Group met last week in Atlanta. The main discussion points were around ICH requirements, multi product submission, facility submissions, linking to other applications, multi regulator submission and how should the project be managed going forward. All current ICH requirements were reviewed. Most of the requirements are already met. Some more requirements need to be addressed. I expect...

Read More

FDA Statistics on NDAs, INDs and ANDAs

This year’s DIA annual meeting was more of a checkpoint rather than revealing startling new information – at least in the eSubmissions area. However, a lot of interesting information was exchanged. Today, I’ll focus on the FDA’s presentations. I’ll follow up later with information from other authorities and industry. Gary Gensinger provided his usual update on eSubmissions at the FDA: In the CDER town hall meeting, Gary noted that FDA...

Read More

ICH Working Group Making Progress on Next Major Version of eCTD

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...

Read More

eCTD on the Agenda at Upcoming ICH Meeting

A public ICH meeting is planned for 14 November 2008 in Brussels, Belgium. See Brussels ICH Public Meeting, Nov. 14, 2008 for the details and agenda. The agenda includes a session on standards development for the electronic exchange of information (chaired by Andrew Marr). That session will include, among other topics, an update on eCTD from Joe Cipollina.

Read More

ICH Publishes Updates to eCTD Specification

ICH has published a new eCTD specification (version 3.2.2) and STF specification (v2.6.1), as promised some time ago. This was done with little fanfare – the announcement and links to the documents can be seen at: eCTD News For those of you who monitor What’s New on the ICH website? – the updates did not merit a mention there. The changes resulted from a June meeting, the documents are dated July 2008 and were...

Read More