EMA, IDMP, SPOR

IDMPrimer #2: EMA’s Operating Model

Last time, the subject was the overall data in IDMP (The ISO standard for Identification of Medicinal Products), and how it grouped into regulatory vs non-regulatory, and the description of the product itself versus what it’s authorized for.

This lesson is about how all that data is going to be used, and how that influences how it will be implemented. In today’s environment, that means Europe and the European Medicines Agency (EMA), because Japan has not expressed any interest in implementing IDMP, and the US is holding by its claim that the current SPL (Structured Product Language) Drug Listings and Establishment Registration is already IDMP-compatible. And it is, mostly, in the same way that a cargo box on the back of a scooter is compatible with a semi-truck because they both have license plates and can carry food).

I like to think in terms of the “carrot and the stick.” There’s plenty of stick, in the form of the EU Parliament law requiring the implementation of IDMP. That was legislated to happen in 2016, which, if you weren’t paying attention, hasn’t happened yet. Instead, the XEVMPD (Extended Eudravigilance Medicinal Product Dictionary) standard, also known as Article 57, is still the way that drug products are registered in Europe. XEVMPD was implemented in 2012 as a stopgap for IDMP: it covers a lot of the same data.

XEVMPD, and IDMP after it, must meet some compliance requirements: Provide a way of uniquely, and universally, identifying medicinal products (the license plate), and deliver knowledge about those products for various purposes (the cargo container).

However, I get the feeling that the EMA’s attitude is, “well, we’re already late, we might as well get this done right, rather than hurrying to catch up.” And that is where the carrot comes in: EMA’s operating model is to make IDMP be more than just a compliance requirement: the drug sponsors should get something out of it too.

This means that in addition to meeting the EU Parliamentary requirements of a database for product safety, there are some goals for IDMP that are beneficial to the drug companies:

  • Integration with the Electronic Application Form (eAF), and the Central European Single Submission Platform (CESSP). CESSP and a new eAF will be delivered sooner than IDMP, so the integration won’t be immediate, but it is a longer-term goal. The objective here is to ensure that the same information isn’t submitted in multiple places. At the very least, CESSP should be able to draw information it needs from the IDMP databases, based on the Medicinal Product ID.
  • Integration with the efforts for the Falsified Medicines Directive (FMD). Again, the objective is elimination of duplicate data. It is expected that all that will be required is to update the FMD with product IDs (possibly down to the batch lot level), and it will draw the rest of the data it needs from the IDMP databases.
  • Integration with e-Prescription initiatives that would permit cross-border prescribing and other international interoperability. This should make marketing of products throughout Europe simpler, a significant benefit.
  • Elimination of certain dossier submissions for minor Quality (Chemistry, Manufacturing and Controls)-section variations, known as Type IA, in favor of just an IDMP record update. Most of these are minor changes to specifications, but form a significant part of companies’ day-to-day regulatory operations. Changing them from a full dossier submission to one XML file in IDMP format could be a significant reduction of effort. What hasn’t been considered is how agencies and companies can track the changes when a product spans both dossier-based and IDMP-based updates.

One thing to remember is that IDMP is big. You just won’t believe how vastly, hugely, mind-bogglingly big it is (apologies to Douglas Adams). It was designed to describe everything about how a medicinal product is made, packaged, approved, and used. That information isn’t easily delivered, as much of it is locked up in the dossier documents used to get the product approved, or in commercial contracts and specifications, as we discussed last time. EMA wants primarily to implement something that can be complied with, and implementing all of IDMP at once would strain most companies. To that effect, a lot of information is put off for a future Iteration. The first Iteration will only cover approved medicinal products (not investigational), and trims back a lot of other data. Items that will not be required in the first iteration include

  • Details on clinical particulars other than basic coding of Indications (no contraindications or interactions, no age ranges, co-morbidity, etc.)
  • Minimal packaging information – in fact this is one area where what will be required is still being hashed out as to. XEVMPD only used a single description field, but IDMP may need more to handle the identifiers on primary and outer packaging.
  • Marketing Status for each country
  • Reference strengths for active ingredients

There are currently 79 fields expected to be required (some of them are repeated as category/value pairs). E-Prescription could add another 12 fields; the Type IA variations would add another 4 – with additional variation types requiring more data in a future iteration. It is expected that during May – or at worst at the June meeting of the EU IDMP/SPOR team (SPOR stands for Substance, Product, Organisation and Referentials, the four pieces of master data in IDMP) – that the list of fields for the first iteration will be finalized. Together, these make what the IDMP/SPOR team is calling the “Minimum Viable Product” or MVP. Contact us to make sure you stay up to date on IDMP developments.

Image credit Brian Harries

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.

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