Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains
Section 3: Implementation Guides
Version 3 Implementation Guide: Regulated Product Submission, Release 1
The Version 3 Regulated Product Submission (RPS) Implementation Guide provides technical details (conformance criteria) on using the Regulated Product Submission (RPS) standard. The RPS standard provides a common means of exchange of documentation and status between product sponsors and regulatory agencies, most of which do not currently have standardized electronic formats. 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. For drugs and biologics, the message format provides benefits beyond the current eCTD and NeES standards by permitting two-way communication, multiple recipients, and changes to granularity and metadata.
Version 3 Implementation Guide: Regulated Product Submission, Release 1 may also go by the following names or acronyms:
- The intended audience of this document is application and software developers that will either create or consume an RPS message. It is likely that specific documentation will be created for regulatory affairs personnel that will explain how RPS will be used for particular product type or for a particular regulatory authority
- Pharmaceutical Companies
- Food Product Manufacturers
- Provides a structured XML message to serve as an envelope for exchange of documents and changes to those documents’ life cycles and metadata
- Facilitates creation of new electronic submission types for regulated product agencies worldwide
- Meets and exceed the capabilities of the ICH eCTD standard for drugs and biologics
- Permits changes in document granularity, e.g. have a single document replace several previously-submitted documents, or have a granular set of documents replace a previously-submitted document
- Permits changes in document metadata, e.g. change the name of a manufacturer, or change the indication a study is submitted under, without having to delete previously-submitted documents and re-add them to the application
- Permits referencing existing dossiers (and their component documents) by the sponsor or other sponsors, without requiring knowledge of the file storage structure at agencies
- US Food and Drug Association (FDA), for Foods and limited use for Drugs
The Regulated Product Submissions (RPS) HL7 standard was created in response to the FDA’s PDUFA (Pharmaceutical Drug User Fee Act) and FDAAA (FDA Amendments Act) requirements to streamline processes, permit two-way electronic communication, and reduce dependence on paper. This was proposed to be a standard message which could be used by all FDA divisions, compared with the existing ICH eCTD standard which is only applicable to Drugs and Biologics.
In addition, limitations of the current eCTD standard in terms of handling life cycle of documents, relationships to other applications and submissions, and dealing with changes in metadata and granularity indicated that a major revision was needed to that standard. The desire of ICH in revising eCTD is to use a standard developed by an international standards body. In 2009, ICH indicated that RPS would become the next major version (NMV) of eCTD.
|Version 3 Implementation Guide: Regulated Product Submission, Release 1||
(Download) (271 KB)
- Regulated Studies
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