Product IG RPS
Product Brief - RPSr1 IG
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Product Name - RPSr1 IG
- HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1
Type
Informative
Releases
Release 1 - May 2008
Summary
The focus of the RPS message allows applicants to submit information electronically. The submitted information is structured as a collection of documents that is organized by a table of contents. The actual table of contents varies from product to product and is defined by regulatory authorities.
The Implementation guide provides technical details (conformance criteria) on using Regulated Product Submission (RPS) Release 1.
The intended audience of this document is application and software developers that will either create or consume an RPS message.
Business Case (Intended Use, Customers)
Regulatory authorities receive submissions to address a variety of regulatory issues. The information contained in these submissions is divided into numerous files (paper and electronic). Frequently, files in one submission are related to files in earlier submissions. Because the information is divided into numerous files sent over time, it is often difficult to efficiently process and review the information.
The goal of the Regulated Product Submission message is to facilitate the processing and the review of submissions.
Uses of this standard indlude
- FDA,
- Pharmaceutical Companies,
- Food product Manufacturers
Benefits
Within the Pharmaceutical industry electronic regulatory submissions have been made using the International Conference on Harmonisation (ICH) Electronic Common Technical Document Specification (eCTD) message [1]. This message is specific to the submission of drug information for regualatory marketing authorization. The RPS message is flexible enough to be used for regulatory submissions for any regulated product including but not limited to food additives, human therapeutics, veterinary products, and medical devices.Although this message can be used for company-to-company communication, the initial intent of this message is for the communication from industry to regulatory authority.
Implementations/ Case Studies (Actual Users)
FDA
Resources
Work Groups
Relationship to/ Dependencies on, other standards
- None
Links to current projects in development
- RPSr2 Project Insight ID# 217
