IDMP Overview December 2015

Agenda Why IDMP? What is driving Standards Substances Agency Adoption

Why IDMP? A Single Source of Truth for Product Information Exchange between Life Sciences Organization and Regulators for improved patient safety. Purpose Support the pharmacovigilance and operational activities of Regulatory agencies through: Unambiguous identification of Medicinal Products across regions Clear mapping of international terminologies (Routes of administration, dosage forms, etc.) for accurate analysis and comparison Identification of all component substances (not only those that are contained in a given safety report)

What is Driving Standards ISO 11238 - SUBSTANCES ISO 11616 – REGULATED PHARMACEUTICAL PRODUCT INFORMATION ISO 11239 – PHARMACEUTICAL DOSE FORMS, UNITS OF PRESENTATION, ROUTES OF ADMINISTRATION, AND PACKAGING ISO 11240 – UNITS OF MEASUREMENT ISO 11615 – REGULATED MEDICINAL PRODUCT INFORMATION

IDMP Data Model - SPOR This is a variation of the IDMP Data Model. It essentially breaks down the 5 standards into their 7 respective areas: Manufacturing: Details of Manufacturing around substances, packaging, pharma products. Additionally it includes the functions out of manufacturing and the integration with regulatory globally. For example supply chain serialization globally. This becomes more complicated depending on the product, think Flu Vaccines Marketing Authorisation: Post marketing information, Registration tracking, Operational/Publishing Packaged Medicinal Products and Devices: IUD, intermediate packaging, secondary packaging, batch identification and release programs. Complex packaging. Pharmaceutical Product: PhPID Medicinal Product: MPID – The Medicinal product Identifier is regional specific, as it includes the Country Code in the identifier and the indication, or indications Clinical Particulars

Now lets speak about the more detailed standard Substances

ISO 11238 – Health Informatics: Substances Single Mixture Element Groups: Chemical Protein Nucleic Acid Polymer Structurally Diverse Substances are defined by two types, Single and Mixture. Mixture is used in cases where there are two substances and due to their combined compounds they are not able to be identified a single substance entities, However in cases where mixture substances can be id’ed at Single, they should be. The element groups in which substances are divide are as follows: Chemical, Protein, Nucleic Acid, Plymer, and Structurally Diverse. Each of these categorizations of the substance leads to the IDMP Id that is assigned

Substance Grouping Group 1: Constituents, physical form and property Group 2: Manufacturing info, group 1 info, production method, type (synthetic, extractive, etc) Group 3: Parent substance, grade and source of grade (pharmacopeia) Group 4: Detailed manuf. Info, constitutes and specifications The substances are then defined by the grouping which they fall. A substance can fall into more than one group, Group 1 being the primary.

Substance Data Requirements At least one substance name or company code Official names should be identified with naming authority, language and jurisdiction One unique identifier (not in order of system acceptance) Non-semantic Random Fixed Length Integrity Check Publicly available Permanently assigned to the identifier Important items to note regarding substance naming: As least one substance name OR company code is required for each substance Official names, registered names, should be identified with naming authority, language and jurisdiction in which it became official One unique identifier is required and not in order of system acceptance: etc etc etc

Agency adoption

GInAS GInAS (Global Ingredients Archiving System) – ISO 11238 Substance Substance Database System Single Global ID for substances and specified substances – Free Application Program Interface New Substances to be registered by authorized agents prior to submission and referred to by the ID in the submission Adoption by: Germany – BfArM Canada – Health Canada Netherlands – CBG-MEB Switzerland – Swissmedic United States – US-FDA European Union – EMA/EDQM Challenges: Closed system with FDA, potentially other agencies Potentially Multiple API’s – User Interface *http://tripod.nih.gov/ginas/index.html

IDMP Implementation Timelines EMA Implementation Date: July 1, 2016 Phases: Preparation Phase: Current – June, 2016 Transition Phase: Product and Substance Pre-Submission: July 1, 2016 – Q1 2017 Product & Substance Submission: Q1 2017 – Q4 2017 Maintenance Phase: beyond Q4 2017 Implementation Guide In Draft Commenting Phase 1 Product and Substance Details – Not Released *iriss-forum.com

IDMP Implementation Timelines FDA Implementation Date: July 2018* FDA is following SPL7 (Structured Product Labeling, Release 87) and the CPM (Common Product Model) for implementation of IDMP *The FDA implementation date is not final

Questions/Discussions Brooke Casselberry, MSRA, RAC Associate Director, Regulatory Paragon Solutions, Inc. bcasselberry@consultparagon.com 1-702-994-1883