Regulated Product Submission(RPS)

Regulated Product Submission Release 1 (RPS) is a Health Level Seven (HL7) standard to facilitate the processing and review of regulated product information. 

Release 1 was approved as an ANSI standard in 2008.

Release 2 is currently being developed at HL7 and expands on release one to include two way communication and information about the submission.

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RPS will speed up the process of sending data to the regulatory.

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One of the current problems with DMFs in eCTD format is the ability to label confidential items differently from public information -- there isn't a way to duplicate many of the eCTD hierarchy items to separate them. In RPS this should not be an issue -- and would be a key benefit -- as it can be done merely with a keyword. This may necessitate an extra keyword, e.g., "Confidential", being available over a majority of eCTD-style context of use items.