Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to help the processing and review of regulated product information. Initiated on June 22nd, 2005, RPS is created for the registration of pharmaceutical products for human use. The purpose of RPS is to meet the goals set by the FDA under the Prescription Drug User Fee Act (PDUFA). RPS is the primary aspect of PDUFA’s five-year plan.

RPS and eCTD share the same ideology of a standardized format for Regulatory submissions including PDF documents and SAS datasets. Though the document structure is same for both RPS and eCTD, the internal XML structures are very different. RPS involves only a single file of XML but due to the complexities of the standard, it is difficult to generate the XML manually.

Objective of RPS

FDA receives many applications addressing a variety of Regulatory issues every year. As the information is divided into various files, the information of one file should always be correlated to the information in another file to efficiently review and process the information. Though the general data is same across all the files for regulated products, different products require different topics to be covered within the submission.

To streamline this issue, RPS has been introduced as an HL7 XML message standard for submitting information to the Regulatory authorities. Each message has Regulatory information which is necessary for the submission. The structure of the message is in a color coded diagram which is represented by R-MIM (Refined Message Information Model). The R-MIM diagrams are designed to capture the necessary information for efficient processing and Regulatory submissions review to explain the information of each message.

Regulatory Product Submissions are crucial and challenging to manage. To know more about them for successful submissions, contact a publishing and submission expert at