1. IDMP Overview
December 2015

2. Agenda
Why IDMP?
What is driving Standards
Substances
Agency Adoption

3. 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)

4. What is Driving Standards
ISO SUBSTANCES
ISO – REGULATED PHARMACEUTICAL PRODUCT INFORMATION
ISO – PHARMACEUTICAL DOSE FORMS, UNITS OF PRESENTATION, ROUTES OF ADMINISTRATION, AND PACKAGING
ISO – UNITS OF MEASUREMENT
ISO – REGULATED MEDICINAL PRODUCT INFORMATION

5. 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

6. Now lets speak about the more detailed standard
Substances

7. 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

8. 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.

9. 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

10. Agency adoption

11. GInAS
GInAS (Global Ingredients Archiving System) – ISO 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 *

13. 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: Q – Q4 2017
Maintenance Phase: beyond Q4 2017
Implementation Guide In Draft Commenting
Phase 1 Product and Substance Details – Not Released
*iriss-forum.com

15. 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

16. Questions/Discussions
Brooke Casselberry, MSRA, RAC
Associate Director, Regulatory
Paragon Solutions, Inc.