ICH, HL7 to Jointly Develop Next Major Version of eCTD

The ICH M2 ESTRI Main Page has been updated with the following announcement: “ICH M2 has initiated the development of the Next Major Version of the eCTD (eCTD NMV) to improve robustness, flexibility and long term stability of the message. In accordance with the decision by the ICH Steering Committee that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards...

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RPS Working Group to Discuss Next Major Version Requirements

The RPS (Regulated Product Submissions) Working Group is preparing for a September 23 working group meeting in Atlanta. Topics include: Discussion of analysis of ICH requirements list (by the way, were you aware that a list of ICH eCTD Next Major Version (NMV) requirements is available?) and multi-regulatory submissions Complexities around two-way communication for Master Files Labeling confidential information File and folder rules...

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ICH Presentation Includes Latest on eCTD, RPS Standards

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...

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