RPS R2 Project

Regulated Product Submission Release 2

Regulated Product Submissions | RPS R2

Scope

The first phase of this project will specifically include submission response (two-way communications), navigational references, and additional descriptive information about a submission (e.g. information currently collected on application forms). The use case for this project is sending the aforementioned content to a recipient (e.g. a regulatory authority, or business partner), sending information back to the original sender, and using application information to report data about the submission. The role pairs include:

• A sponsor submitting to a regulatory authority,
• A CRO submitting to a sponsor
• A sponsor submitting to a collaborator
• Transfers of information between regulatory authorities (e.g. submission of a device containing a drug where the EU Notified Body sends data to a competent authority for review).

Specifically the first phase work entails:

• Two-way communication
• Minutes and general correspondence (related to two-way communication) including pre-submission information•
• Referencing in backbone (Master Files, Other submission/application information, Pre-submission information) hyperlink content to other content
• Providing information about the submission (e.g. meta-data, information currently collected on application forms)
• information about the product; Contact Information, Manufacturing site
• Semantic interoperability with RCRIM and relevant HL7 domains.

Support for phase 2 work by ICH, GHTF, international device regulators and the ISO/CEN/HL7 Joint Initiative

Scope Inclusions:

• Correspondence to and from either sponsor or regulatory authority

Scope Exclusions:

• Enhancements to the PDF standard
• Transmission protocols (secure gateway, FTP, etc.)

Deployment of the Regulated Product Submission messages will be successful when the following conditions have been met:

• Capable of supporting the ability to a secure electronic single point of entry to include two-way transmission of regulatory correspondence.
• Capable of supporting an automated, standards-based, regulatory submission and review environment for all submission types and their supplements that enables the following functions and supports the life cycle of the product

1. Electronic submissions received by a regulatory authority can be archived to enable retrieval through standardized automated links;
2. Electronic submissions can include cross-references to previously submitted electronic materials through standardized automated links
3. Archived electronic submissions can be retrieved through standardized automated links; and
4. It is intended that RPS will be applicable to human drugs and biologics, medical devices, foods, and animal health products.

• Project deliverables have been vetted and approved
• Project risks have been mitigated or the contingency action has been implemented
• Negative ballots have been reconciled

Domain Analysis

The RPS Release 2 is driven by business needs in the regulated product domain as that align to one of the three scope statements; two-way communication, referencing and forms data. The project group has reviewed each of these scope statements in order to align the business cases for each of the areas that will be outlined in this section to support the need for RPS R2.

Two-way Communication The area of two-way communication relates to all of the activities in with one party corresponds with another on regulatory topics. The communication that occurs between two parties will need to be related to a regulated product submission. The parties may be corresponding about one or more of the following items:

• Discuss Submission activities – including the correspondence for meeting requests, scheduling meetings, distributing meeting minutes or follow-up documentation (i.e., plans or action items), and any other correspondence that my be handled via a brief exchange of information in a letter or other form of correspondence (i.e., email, fax or phone call).
• Communicate Additional Information Requests – including the bidirectional flow of questions and responses related to documentation, missing documentation, no related documentation or technical issues. This communication is often not completely addressed in one exchange; there may be multiple attempts to resolve the questions posed by the initial party. This correspondence should be able to handle both complete and partial responses.
• Communicate Regulatory Actions – including correspondence of both formal and administrative regulatory actions as a result of a regulated product submission. The Regulatory Authority will communicate the initial and any subsequent formal regulatory actions for one or multiple submissions based on the review of product information submitted. The administrative regulatory actions include actions that related to specific regulations and may be to reclassify a product, product submission type and/or submission sequence (i.e., serial number, submission number, sequence number).
• Review Information Interactively – including the informal communications between two parties to ensure information is shared during the review of a regulated product submission. This type of collaboration and/or interactive process will need to be evaluated further within the context of RPS R2.

Referencing The area of referencing has a very specific meaning in RPS R2. The referencing of an application, submission or submission unit that was submitted by the parent company to the regulatory authority for the specific use by one or more companies. The regulated product submission is provided and permission is granted to companies to refer to a particular submission when the product components make up another regulated product.

• Referenced Applications/Submissions/Submission Unit – pertains to a company’s use and reference to another company’s master file and/or master access file. This type of submission provides the component specific information for a product (i.e., containing trade secrets and/or proprietary information) for which another company manufactured a part or parts of the product. In addition, a company may need to reference product-specific documentation that was submitted with the sole intent of providing third-party documentation (i.e., independent verification and validation testing results) that cannot be disclosed directly to the company manufacturing the regulated product.
• Reference Document in External Warehouse – relates to a company’s reuse of information (i.e., submission content) that is stored in an external warehouse. Currently, this business case relates to the Annotated ECG warehouse. There may be other warehouses in the future.
• Reference within Documents – pertains to the hyperlinking of one part of a document to another part of the document; or the hyperlinking of one part of a document to another part of a related document.

Information about the Submission The area of forms data refers to the collection of information and/or data about a submission unit. Often regulated product submissions require the company to complete a form for the purpose of providing information to the regulatory authority about the product, applicant and related manufacturing facilities. This information may be used for multiple purposes by the regulatory authority including, but not limited to submission processing, submission review and approvals. Regulated Industry will need to be able to add, modify and delete data submitted to the Regulatory Authority throughout the life of a product.

Regulated Product Submissions | RPS R2