Project Summary for Regulated Product Submission Release 3 (RPS R3)
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Project Details
Number | 539 View Ballot Items List (with NIBs) |
---|---|
Name | Regulated Product Submission Release 3 (RPS R3) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | |
Steering Division | Clinical |
Description | The RPS R3 project scopes builds on the scope defined in RPS R1 and RPS R2. RPS R2 incorporated medical device and international requirements, but the focus was on the United States Food and Drug Administration (US FDA) requirements to meet Prescription Drug User Fee Act (PDUFA) IV electronic submission commitments. RPS R3 expands on the R2 requirements and aims to complete the definition of the message standard to support the following global regulatory product submissions* activities: 1. Two-way communications (including interagency (multi-regulator) communications, and expansion of current two-way communication activities). During development it was determined that there was no business need for 'threaded discussions' functionality, so this was dropped. Management of multi regulator communications is also featured in aspects of the EU regional requirements. 2. Referencing (e.g., application to application, submission to submission, etc.) - This will include requirements for referencing applications/submissions not 'owned' by the submitter (e.g., Master Files). 3. Lifecycle management, including the complex relationships of documents in European regulatory processes (management of the Mutual Recognition Procedure and the new Variation regulation that allows single submission units to be submitted that contain changes for multiple products) and other requirements brought forward by stakeholders. 4. Additional information about the submission (e.g., product, sender/recipient, document/element/leaf metadata), building on the R2 set by aiming to achieve an aligned information set that can be used on an international basis. Review during development determined that a CMET from the Common Product Model was not needed 5. Any Hyperlinking issues that have been identified. During development it was identified that the so-called 'broken hyperlink' issue is a technical issue associated with the way that PDF files manage link information and that it was not possible to use the RPS message to correct this deficiency, so the objective of fixing this issue was dropped. Other linking or information relation requirements may also be identified. 6. Specifically for this project, the scope will include the full definition and inclusion of the international requirements brought forward by the ICH as part of the development of the eCTD version 4.0 for submissions in the human pharmaceuticals area. The project will also include updates and requirements from other stakeholders in the healthcare community, as notified to the project. a) The ICH requirements (v1.0) were forwarded to the RPS project in late 2009 for an initial review and further updates have been provided during the project. Full delivery of these requirements, plus any others that arise during the R3 project requirements development, will come from this project unless otherwise agreed by the ICH representatives. 7. Regional requirements that are needed to support the global adoption of the standard by industry domains, particularly relating to the eCTD version 4.0. a) For example, the EU wants to include information about the status of a regulatory activity in the message to support the lifecycle viewing of the product submission. They also have requirements that will help support the multi product submission types needed to support the local variation regulation. b) It is expected that other ICH regions and observers will bring regional requirements to the RPS R3 project. This seems likely based on the ways in which these regions have implemented the existing ICH eCTD specification to meet their regional requirements. 8. The update to the Implementable Technology Specification (i.e., migration from ITS 1 to ITS 2) 9. It is expected that the implementation of the RPS R2 DSTU standard may identify further changes to the basic RPS information model that should be included in the RPS R3 release. Two items to be delivered as part of the scope are: 1. The RPS R3 Domain Analysis Model will also be balloted as an Informative ballot package and will be in harmonization with the BRIDG v3.x model. This is part of the ongoing effort across all RCRIM sponsored standards to ensure that they are compliant with the BRIDG Domain Analysis Model. 2. A plan for the further progression from the HL7 RPS R3 Normative Standard to an ISO (and CEN) standard. The ICH development work is dependent on the final standard for their implementation purposes to be an ISO and CEN standard. Other stakeholders rely on the ISO to formally adopt and implement standards and may also benefit from the progression from HL7 to ISO standard, though it is also recognised that they may work with other technical committees within ISO. * Currently, the product submission areas included in the scope are conventional and biological human pharmaceutical products, medical devices and veterinary medicines. Additional product areas may be included with appropriate participation in requirements gathering and development by representatives from those product areas. |
Project Facilitator | Geoff Williams (EFPIA) |
Status | Archived |
SD Approval Date | Apr 22, 2011 |
TSC Approval Date | May 2, 2011 |
Type | Ballot - STU |
Objectives / Deliverables | The RPS R3 normative standard - Target: June 2012 An implementation guide for the normative standard - Target: June 2012 Ballot of the RPS R3 Domain Analysis Model. - Target: June 2012 Aligned vocabularies for the implementation of the standard by the various stakeholders. - Target: February 2013 The plan for moving the standard to an ISO standard - Target: June 2012 Project End Date (all objectives have been met) - Target: February 2013 |
Next Milestone Date | 2016 September WGM |
Project End Date | 2016 September WGM |
Project Intent | Revise Current Standard, Supplement to a Current Standard, Implementation Guide |
Project Need | Several healthcare regulatory agencies are seeking a single electronic message specification to manage the entire spectrum of regulated product submission types that they deal with (e.g. human pharmaceuticals and biologicals, medical devices, veterinary medicines, etc. In addition, key stakeholder harmonisation initiatives, such as the ICH, are seeking to develop their existing standards using the processes of an accredited SDO. |
Implementers | 1) FDA (Gary Gensinger) 2) EU Regulatory Agencies (Stan van Belkum) |
Security Risks | |
External Drivers | |
Common Names / Keywords/ Aliases | |
Lineage | |
Dependancies | #217 - Regulated Product Submission (RPS R2) Note: The development of RPS R3 will begin while the RPS R2 standard is at DSTU #456 - Common Product Model Note: Development work will determine the level of dependence on this project |
Project Document Repository |
HL7 RPS Wiki: http://wiki.hl7.org/index.php?title=Regulated_Product_Submissions Gforge: http://gforge.hl7.org/gf/project/rcrim/docman/ |
Backwards Compatibility | Yes |
External Vocabularies | |
Products | V3 Documents-Administrative (e.g. SPL) |
Joint Copyright? | |
External Pjt Collaborators | ICH (ICH is made up of six parties representing the human pharmaceuticals industry and regulators from three regions. US: PhRMA and FDA; EU: EFPIA and European Commission (on behalf of the National Competent Authorities); Japan: JPMA and MHLW/PMDA). ICH has identified the RPS R3 project as the means to deliver the eCTD version 4.0 standard, and moving this through to an ISO standard. This is an informal relationship. Health Canada. Health Canada has adopted the ICH eCTD and is working on the ICH team to implement the eCTD version 4.0. Health Canada are also interested in the use of the standard for Medical Devices and Veterinary Medicinal products. This is an informal relationship. |
Realm | Universal |
HL7 Affiliate | |
Stakeholders | Regulatory Agency, Other (specify in Misc. Notes below) |
Vendors | Other (specify in Misc. Notes below) |
Providers | |
Ballot Cycle Info | 2014 Sept Ballot Cycle Info: NORMATIVE Ballot results: Met basic vote requirements. 0 Negatives to reconcile Document Name: HL7 Version 3 Standard: Regulated Product Submission, Release 2 Submitted By: Edward Helton PhD 2013 Sept Ballot Cycle Info: NORMATIVE Ballot results: Did not meet basic vote requirements. Document Name: HL7 Version 3 Standard: Regulated Product Submission, Release 2 NIB Submitted By: Edward Tripp 2012 Jan Ballot Cycle Info: DSTU Ballot results: Met basic vote requirements. 18 Negatives to reconcile Document Name: HL7 Version 3 Standard: Regulated Product Submission, Release 2 Ballot Code: V3_RP_R2_U2_2012JAN NIB Submitted By: Edward Tripp 2011 Sept Ballot Cycle Info: DSTU Ballot results: Did not meet basic vote requirements. 38 Negatives to reconcile Document Name: HL7 Version 3 Standard: Regulated Product Submission, Release 2 Ballot Code: V3_RP_R2_U1_2011SEP NIB Submitted By: Edward Tripp ICH (ICH is made up of six parties representing the human pharmaceuticals industry and regulators from three regions. US: PhRMA and FDA; EU: EFPIA and European Commission (on behalf of the National Competent Authorities); Japan: JPMA and MHLW/PMDA). Agreement status: Informal ICH has identified the RPS R3 project as the means to deliver the eCTD Next Major Version (NMV) standard, and moving this through to an ISO standard. Health Canada. Agreement status: Informal. Health Canada has adopted the ICH eCTD and is working on the ICH team to implement the eCTD NMV. Health Canada are also interested in the use of the standard for Medical Devices and Veterinary Medicinal products. |
Misc Notes | August 2015: NE 2015 published; PMO archiving project. 2015 July: Received ANSI approval for HL7 Version 3 Standard: Regulated Product Submission, Release 2. PMO setting status to 'Ready for NE Publication'. No further work needed from Project Team. April, 2011: Scope changed and RCRIM sent modified PSS through SD and TSC Approval. Nov2010:(LL) Per RCRIM three-year plan, DSTU Development starting in 2011Jan cycle, intending to ballot DSTU 2011May, Normative 2012May, Publication 2012 Sept. Updated milestone dates. Mar 2010 G. Williams: There was some possibility that R2 would proceed to a normative standard while development work on R3 was taking place. We expect now that R2 will not advance beyond DSTU, and that further development of the standard will be rolled in to the R3 project. R3 is really a second development phase in the R2 work. However, people in the project understand the distinction between the work that we call R2 and the work that we call R3, so it would be counterproductive for us to try and communicate with everyone what is just a naming convention change. As a minimum, can we hold off any further conversation on what release number to call the standard until the end of 2010 when we will be much clearer on our plans for the DSTU testing of R2 and the development of requirements for R3. As I noted above, ideally, I would keep the nomenclature being used currently through to completion, which would mean that the Normative Standard would go from R1 to R3, but the RPS team would be happy to reconsider this as we go along. 2010July: updated project repository URL Other Stakeholders include the Pharmaceutical and Medical Devices industry Other Vendors include the prioviders of Document Management and Publishing IT solutions |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Sep 11, 2009 |
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