1. Regulated Product Submissions Goals and Scope Jason Rock Jason.Rock@GlobalSubmit.Org 856.854.4455 x105

2. Goal Create regulated product submission message (meta-data) –General enough to handle all regulated products –Enough information to allow regulators to support structured review

3. Scope Animal and Human products –Including but not limited to food additives, human therapeutics, veterinary products, and medical devices Worldwide use –Same message structure for all product types –Different controlled lists (keywords/topics) for each product type

4. Out of Scope Content –For example: Regulators will review either the message or the eCTD in the same fashion (same review tool) Document content will not change

5. Compare HL7 Message to ICH eCTD Topics/Keywords based on ICH eCTD HL7 message is equivalent to index.xml, xx-regional.xml, and all STF-.xml

6. Work to date Project initiated June 22 nd 2005 –Leveraged existing Human Pharmaceuticals experience (ICH/eCTD) DSTU Ballot –23 Storyboards (requirements) –Defined 6 entities and numerous properties –Message model (13 Acts) –Documented R-MIM (introduction and walkthrough) Distributed sample message Testing meeting June 18 th 2006

7. Subsequent release of standard Provide information about the submission (e.g. information currently collected on application forms) Two-way communication Linking to Master Files