ARIM Registrations, EMA, IDMP

IDMPrimer #1: The Four Quadrants of IDMP Data

Once upon a time, I’d written a number of lessons on IDMP – those are no longer easily available (hint: check out the Internet Archive, but come back here), and there have been changes, so let’s start from scratch. If you need a glossary of abbreviations below, please check out the April 25 blog post.

What is the purpose of IDMP, and existing similar technologies for medicinal product registration such as EMA’s XEVMPD and the FDA’s Drug Listings and Establishment Registration? Primarily, it’s a record of what the agencies have approved for use, in a machine-readable form. This data assists in a wide array of health-related objectives:

  • Tracking adverse experiences, including finding relationships between products
  • Serving as a list for facilities auditing
  • Helping prevent medication prescribing errors
  • Tracking counterfeit, stolen or contaminated product
  • Identifying medications outside of their packages

So what is needed to supply that data? It all boils down to two things:

  1. What the product is (how and where it’s made and packaged, what it looks like)
  2. What it’s been authorized to be used for (marketing approvals, clinical trial authorization)

The next question is, which of this data does Regulatory have at hand.  That’s a little trickier of a question, and may vary from company to company, depending on how affiliates are handled, and whether Regulatory includes a Chemistry Manufacturing and Controls (CMC) group.  Let’s assume they do, and we can divide IDMP data up as follows (color coded to match the ISO IDMP data diagrams).

What it is What it’s authorized for
Regulatory PhPID
Package Items
Package Components
Package Data Carrier Identifiers
Characteristics
Manufactured Item
Storage Conditions/Shelf Life
Devices
Manufacturers
Ingredients
Pharmaceutical Product
Strengths
Route of Administration
Dose Form

MPID/IMPID, PCID, BAID
Classifications (e.g. ATC)
Documents
Product Name
Pharmacovigilance Master File Location
Orphan Designation
Cross References to Other MPIDs/IMPIDs
Marketing or Clinical Authorisation, Procedure, Application
PSURs
Establishment Details & Authorisations
Package Authorisations
Indications/Contraindications
Interactions
Adverse Events

Others Package Details

Marketing Status, Events, Suspensions
Marketing or Clinical Authorisation, Procedure, Application (Afflilates)
Establishment Details (Other Regions)

As you can see, the vast bulk of the information is available to regulatory, but there are some areas that fall into commercial operations (market suspensions, and packaging details such as the exact size, materials and data carrier identifiers) or foreign affiliates (foreign authorisations and establishments). Please note, though, that not all of this data will be needed at once: EMA is planning an “iterative rollout”, and many of the categories in all four quadrants are scaled back for the first iteration due to be implemented in 2019.  For instance, indications will be included, but not contraindications, interactions or adverse events. If your regulatory is tightly centralized — affiliates are few, or controlled tightly by HQ regulatory — you may have little trouble with the bottom right information, except for the marketing status changes.

Meanwhile, the left half corresponds to more classic Product Life Cycle Management – what ACUTA ARIM 3.0.1 calls the Formulation, and the right half to classic Regulatory Tracking, what ARIM calls the Application and Registration. Getting these all together is going to be a big part of the challenge. We’ll explore more of this, and how it relates to ACUTA ARIM in future posts. If you’re looking to get started now, please contact us so we can help you start down the path for IDMP.

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

Leave a Reply

Your email address will not be published. Required fields are marked *