ICH Presentation Includes Latest on eCTD, RPS Standards

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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 short

Author: GS

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