1. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 The HL7 RPS and SPL Standards - A High Level View Terry Hardin Sr. IT Architect Emerging Software Standards, IBM DIA ERS SIAC January 17, 2008

2. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 Topics What is RPS? RPS Timeline RPS Components What is SPL? SPL Timeline SPL Components Draft PDUFA IV Milestones and Strategy for RPS and SPL

3. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 RPS – Background, Focus & Components

4. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 What is RPS? RPS = Regulated Product Submission A Health Level 7 (HL7) standard intended to address multiple submission types - including those outside of human pharmaceuticals Initially targeted to address global health authority requirements Makes use of XML technology

5. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 What is RPS? Use XML to Describe: - dossiers overall - dossier sections - documents - relationships between documents or sections

6. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 Challenges Address submission types outside human pharmaceuticals – Vet, Food, Devices Have a “global” perspective Keep in mind current business process (eCTD) Keep in Mind Past Lessons Learned – for example from the eCTD and HL7 SPL

7. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 RPS Timeline Initiated 2005 –Wanted to leverage existing ICH eCTD work HL7 DSTU – Passed May 2006 –There were a set of 23 “storyboards” or requirements –Testing started based on requirements –First FDA test submission, Sept 2006 –Testing results were incomplete by Jan 2007 HL7 v1.0 Normative Standard, April 2007 –Passed ballot with a number of issues –Approved for FDA with regard to animal, foods and devices submissions

8. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 RPS Overview Reuse of Documents –By use of unique ID’s Product/Submission Management –Grouping based on message “units” –Application, Submission, Submission Units Categorization –Context of Use –Keywords

9. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 RPS Components Application –A group of submissions (“e.g. NDA, PMA”) Submission –A group of one or more submission units –In terms of an eCTD, a group of sequences –“e.g. original, supplement, variation” Reviewable Unit –Organizes a set of documents and data into discrete reviewable entities –“e.g. clinical”

10. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 RPS Components (2) Submission Units –A set of documents and data submitted to a regulatory agency at a specific time –In terms of the eCTD, one sequence Context of Use (“Table of Contents Heading”) –How documents/data are used in a specific submission unit –Protocol, Study Report, etc. Keyword –Further categorization of documents/data –Manufacturer #1, Animal Study, Food Color Study, Legacy Study Report

11. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 SPL – Background, Focus & Components

12. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 What is SPL? SPL = Structured Product Labeling A Health Level 7 (HL7) XML standard for the exchange of product information with the FDA Allows the XML to be submitted “stand alone” or as part of an eCTD submission Developed in an HL7 working group (RCRIM) – with FDA participation

13. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 SPL Timeline Adopted by CDER October 2005 Used to model existing labels Constraints defined by FDA implementation guide “Beginning June 30, 2006, content of labeling submitted to the Agency should be in the new format required in the Physician Labeling Final Rule (PLR) (21 CFR 201.56 & 57)”

14. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 SPL Focus Content NOT format Allow updating of Product Information (PI) - to be used in place of the MS Word PI documents End user via daily med site eSubmission – either stand alone or as part of an eCTD

15. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 SPL Components HL7 Standard FDA Documentation: Implementation Guide, Stylesheets, etc. FDA SPL Review System (ELIPS) Associated business process changes SPL schema to define how a SPL submission should be formed to be valid

16. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 SPL Includes Content of labelling - narrative text of the labelling describing how and when to use medication Drug listing data elements or the structured format for describing the drug product including ingredients and packaging “Highlights” data elements - structured format for describing drug indications, drug class, drug interactions and adverse reactions

17. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 PDUFA IV Draft IT Plan – Milestones & Strategy: RPS & SPL

18. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 DRAFT PDUFA IV – Milestones RPS –Implement/Accept RPS Submissions in 1Q08 for: SPL Submissions to a Paper NDA/BLA Electronic datasets for paper IND/NDA/BLA Single investigator IND –RPS Release 1 HL7 Implementation Guide ready to be balloted 2Q08 –Target for addressing PDUFA requirements, RPS DSTU Release 2 – HL7 Ballot 3Q08 *NOTE: This information is from the Draft PDUFA IV IT plan, December 2007

19. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 DRAFT PDUFA IV – Milestones SPL –Electronic Listing to provide the ability to automate drug listing information and validation processes (SPL data elements to be extracted and reused). Prototype to be tested by FDA and Industry starting 1Q08. Release 1 targeted for 2Q08. –Collaboration Portal (CP) to provide a web based collaboration platform where applicants and the FDA can review and negotiate SPL labels. Prototype to be tested by FDA and Industry starting January 2008. –ELIPS Updates *NOTE: This information is from the Draft PDUFA IV IT plan, December 2007

20. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 DRAFT PDUFA IV Reference Link to FDA PDUFA IV Draft IT Plan http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0481-gdl0001.pdf

21. © Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 Thank You! Terry Hardin IBM