eCTD on Twitter
- Malta: Requirements on Electronic submissions for New Applications within National and European procedures #ectd
http://bit.ly/9m1pQl2010/09/08 09:39 - Check out Reed Tech's LabelDataPlus super search tool for SPL, searching repository of of 27052 drug labels:
http://bit.ly/cYdc982010/09/07 12:03 - Highlights of IRISS Interoperability group’s July, August mtgs posted, incl some FDA news
http://bit.ly/bPEeEN & http://bit.ly/brD5OY #ectd2010/08/31 10:07
Search
Visit GlobalSubmit
The eCTD Company™
Archive for February, 2009
This is not really new news, but ICH has posted the short presentation ”Update on the eCTD“ from the November meeting on their website. This presentation was given by Joe Cipollina.
The key elements of the presentation include:
-
ICH eCTD requirements will be submitted through the SDO Joint Initiative into the HL7 Regulated Product Submission (RPS) standard, Release 2
-
RPS R2 is currently under development to provide a single electronic message standard for multiple regulated industries (drugs, vet meds, devices, food)
The ICH M2 Group focus will be to:
-
Ensure inclusion of globally harmonised medicinal product requirements
-
Identify subset of RPS R2 relevant to ICH needs
-
Create implementation guidance to provide improved instruction for creating eCTDs
So it’s official, folks - RPS is coming!
It’s time to get educated. In a previous post, I mentioned the RPS wiki and list server.
Also, keep your eyes on my company’s web site www.globalsubmit.com. My colleague Jason Rock, who serves on the leadership steering team that is developing RPS, will be presenting a series of RPS educational sessions at the request of the FDA. You will be able to register for these sessions on our website shortly.
(0 Comments)
SwissMedic announces plans for accepting eCTDs
posted by Kathie Clark @ 8:47 PM
Tuesday, February 3, 2009
The Swiss Health Authority Swissmedic intends to accept starting applications for admission in the eCTD format, i.e. in electronic form without paper documentation, starting in January 2010. The announcement is available (in German) on their website.
In support of this goal, Swissmedic initiated project SIMES (Solution for the implementation and the management OF electronics tender in December 2008.
The agency intends to largely follow European Union specifications with exception of module 1.
The project milestones include:
-
January 2009: Project Kickoff
-
Starting from March 2009: Publication of project information on the Swissmedic homepage (project status, Q& A-paper, announcements, etc.)
-
July 2009: The first version of the eCTD specification and the Praxisguidelines Swissmedic are available for the notification and examination. Submission types suited for the eCTD format are defined.
-
October 2009: The final version of the eCTD specification and the Praxisguidelines Swissmedic are available.
-
January 2010: Applications for admission in the eCTD format are accepted for defined submission types.