RPS R3 Project Scope Statement

Project Scope Statement Document

The following documents are the working versions of the RPS R3 Project Scope statement:

Project Scope (section 4 - version 0.9 - January 4, 2010)

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: • Two-way communications (including interagency (multi-regulator) communications, and expansion of current two-way communication activities) – This includes “threaded discussions”, dividing and tracking regulator information requests and the responses into individual items. • 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). • Lifecycle management • Additional information about the submission (e.g., product, sender/recipient, document/element/leaf metadata) • Hyperlinking (i.e., Broken Link) – This includes management of document links within and across documents and/or submission units.

• 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.

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 Next Major Version 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.

It is noted that by including the global requirements, there will necessarily be some fairly diverse regional requirements brought forward that must be consolidated within the overall scope of the standard developed.