Regulated Product Submissions
Regulated Product Submission (RPS) is a
Goal of RPS
Authorities such as the FDA receive numerous submissions that address a variety of regulatory issues. The information contained in these submissions is divided into large numbers of files, both paper and electronic. Often, files in one submission are related to files in earlier submissions. Because the information is divided into numerous files sent over time, it can be difficult to efficiently process and review the information.
While the general data layouts of all regulated products are the same, different product types have different lists of topics that must be addressed within the submission. Therefore, the goal of RPS is to create an HL7 XML message standard for submitting information to regulatory authorities.[3] Each message includes the contents of a regulatory submission plus information such as metadata, which is necessary to process submissions.[4] The Refined Message Information Model (R-MIM) shows the structure of a message as a color-coded diagram. R-MIM diagrams are designed to capture all required information for the efficient processing and review of regulatory submissions and to explain what each message consists of. This makes RPS general enough to handle all regulated products while containing enough information to allow regulators to support structured review.[4]
Origins
The project to develop a regulated product submission standard was initiated on June 22, 2005.
RPS structure
As the industry moves away from paper submissions, global companies producing regulated products will benefit from having a published electronic submission standard. The label of “regulated product” applies not only to pharmaceuticals, but also extends to include food additives, medical devices and radiologics, human therapeutics, biologics, tobacco products and veterinary products.[2]
The submitted information is structured as a collection of documents, organized by report sections. Multiple documents can be assigned to a single report section. The actual table of required and optional report sections varies from product to product and is defined by regulatory authorities. Since the same information can be submitted to support multiple applications, it is imperative that RPS allow for the reuse of data between applications.
RPS and eCTD
RPS is in many ways comparable to the
Future releases and implementation
Release 3 will be headed by ICH. The goal of release three is to have more international requirements. The HL7 standard will be implemented first at the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) in late 2011, before being rolled out to the other centers using a yet-to-be-determined schedule. Both centers will implement Release 2 of RPS, which barely passed ballot as a Draft Standard for Trial Use (DSTU) in January 2010.[6] The ballot passed by two votes with a result of 53 affirmative and 33 negative.[6] Testing by FDA is expected to begin at the beginning of the third quarter, 2010.[6] When RPS is implemented, FDA will offer a training program for reviewers, including hands-on training classes.[2]
References
- ^ "ICH-HL7 Regulated Product Submissions". GlobalSubmit.com. 2009.
- ^ a b c d e f g h i j k l Ann Neuer (June 22, 2009). "Will Regulated Product Submission (RPS) Trump eCTD?". Bio-IT World.
- ^ "RCRIM Project Proposal–Regulated Product Submission". hl7.org. May 2005.
- ^ a b c d e "HL7 Regulated Product Submissions Goals and Scope". hl7.org. 21 April 2006.
- ^ a b c Mark Gray (June 2009). "CDER eSubmission Update: Regulated Product Submission (RPS) Update". 45th DIA Annual Electronic Submissions Meeting powerpoint presentation.
- ^ a b c Jason Rock (January 20, 2010). "Regulated Product Submission (RPS) Clear First Hurdle". The eCTD summit.
External links
- FDA Data Exchange Standards Initiatives: Regulated Product Submission (RPS) Standard Status
- Regulated Product Submissions (HL7 Wiki)
- Guidance for HL7 Regulated Product Submissions
- RPS Terminology Map by Country and Industry
- Agency Presentations
- EMEA eCTD/NMV RPS
- Analysis: New ICH M2 Requirements into eCTD NMV (=RPS)