RPS Ballot Passes, Working Group Now Evaluating Comments

Our posting this time is from Jason Rock, GlobalSubmit CTO and Chair of the HL7 RPS Specification Development Group. The Draft Standard for Trial Use (DSTU) ballot of the Regulated Product Submission Release 2 standard barely passed ballot on Monday January 11th. The ballot passed by two votes with a result of 53 affirmative and 33 negative. Even though the ballot passed, the process is not over. Every comment must be evaluated. This...

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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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Japan Presentation Compares eCTD to RPS

I was not able to attend the HL7 Working Group meeting in Japan last week, but I did give an RPS education session remotely. The agenda including the background of RPS, the foundation of the standard, document lifecycle, release two of the standard and a comparison of RPS to eCTD. In the background section we discussed the goal, scope, how the project was initiated and the project’s acomplishments. In the foundation section we...

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eCTD, RPS Best Practices

GlobalSubmit (the company I work for) has recently enhanced its website to include a considerable amount of eCTD and RPS-related reference material. Check out our Best Practice pages for practical information on a variety of topics, including: Technical Rejection Avoidance eCTD Reviewing eCTD Validation eCTD Content eCTD Readiness Document Templates Study Tagging Files (STFs) Granularity, and Submission Outsourcing. We have also...

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Latest News on RPS Version 2

On July 24th, 2008, a kickoff meeting was held at FDA’s Whiteoak facility for Regulated Product Submission (RPS) Version 2. For those of you who have not been following RPS, it is a Health Level Seven (HL7) standard to facilitate the processing and review of regulated product information. The goal of RPS is to create a regulated product submission message that: Is general enough to handle all regulated products such as drugs,...

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