Regulated Product Submission (RPS) is the Health Level Seven (HL7) XML message standard for submitting product information to regulatory authorities. RPS is very similar to the electronic Common Technical Document (eCTD) standard created by the International Conference on Harmonization (ICH) for the registration of pharmaceutical products for human use and is often referred to as eCTD V4.
RPS covers all regulated products/medical devices and involves a single XML file. Even for experienced users, XML can be quite complicated. The complexities of the RPS standard make it extremely difficult to generate RPS XML by hand. RPS is being developed in response to performance goals that the U.S Food and Drug Administration (FDA) have to achieve, as outlined in the Prescription Drug User Fee Act (PDUFA). RPS is a significant element of the PDUFA’s five year plan. The regulatory agencies of Europe, Canada & Japan have shown varying levels of interest & participation.
RPS Vs eCTD
|Organize applications and regulatory activities||Flat structure|
|Single XML File||Multiple XML Files|
|Folder structure undefined||Folder hierarchy and names defined by guidance|
|Attributes globally defined and assigned at the file level||Attributes assigned at folder level – some at file level|
|Attributes can be corrected||Attributes cannot be corrected|
|Virtual TOC: Documents appear in a browse-able structure based purely on their metadata||Electronic TOC: Documents appear in a browse-able structure based largely on how their leaf nodes are linked into an overall hierarchy of leaves|
|Structure created externally by a viewing tool – otherwise only a flat file list would be seen||Structure inherently part of the XML and appears within any web browser|
|Allows for regional or product differences in organizing documents into a TOC||Cannot easily add new content for regional differences or other regulated products|
|Re-use documents across applications formalized||Re-use documents across applications not formally described and subject to specific regulators’ rules|
GOAL OF RPS
- To create an HL7 XML message standard for submitting information to regulatory authorities
- The Refined Message Information Model (R-MIM) shows the structure of a message as a color-coded diagram
RPS RELEASE 1
The project to develop a RPS standard was initiated on 22 June 2005. RPS RELEASE 1 was spearheaded by Jason Rock of Global Submit, a US-based company dedicated to facilitating electronic regulatory submissions between life science companies and regulatory agencies worldwide. The aim was to create one standardized submission format to support all of the FDA’s electronic product submissions.
RPS RELEASE 1 provides the capability to cross reference previously submitted material owned by the sponsor as well as append, replace and delete parts of the document lifecycle. RELEASE 1 was approved in 2008, but was not suitable for EU and Japan.
RPS RELEASE 2
RELEASE 2 was led by Peggy Leizear of the Office of Planning at the FDA. RPS RELEASE 2 grants the ability to exchange contact information, classify submission content and handle multi-region submissions. RELEASE 2 of RPS also handles two-way communication-between the Regulatory Authority and the Submitter. Both the parties involved will use RPS to send correspondence (e.g. request for additional information, meeting minutes and application approval).
RPS RELEASE 2: WINS VOTE at HL7 TO BECOME NORMATIVE STANDARD
The Regulated Product Submissions (RPS) standard, in development since 2005, is a normative standard as of 8th September 2014, following its win at the Health Level Seven (HL7) summit.
When the votes were counted, RPS Release 2 didn’t get a single negative vote and is well on its way to become an ANSI standard in future. This is the first major step towards the creation of the electronic Common Technical Document (eCTD) version 4.
RPS IMPLEMENTATION TIMELINE
RPS will be implemented in the US in 2016 and EU and Canada in 2017, according to industry sources.
FUTURE RELEASES AND IMPLEMENTATION RPS RELEASE 3
Beyond HL7/ANSI accreditation, they need implementation guides from ICH and regulatory agencies, and approval as an ISO standard. With those guidelines RPS RELEASE 2 will come out as RPS RELEASE 3, which is likely to happen in 2016 or early 2017.
- It will be headed by ICH
- The goal of RPS RELEASE 3 is to have more international requirements
RPS ADOPTION FOR A PHARMACEUTICAL COMPANY
Adoption of an electronic submission process that leverages RPS means a pharmaceutical company can
- Increase their profitability goals
- Automate their inefficient paper processes and
- Significantly reduce their costs