ARIM, EMA, IDMP

And if IDMP never happens?

Well, for one, it will. European Parliament has legislated that it must.  But it could come in many different forms, perhaps with nothing more than the minimal data to determine a Medicinal Product ID that gets used on an Adverse Event Report. That means the following items are the barest minimum of data that must be collected to implement IDMP:

  • Marketing Authorisation Country, Number and Date
  • Legal Status of Supply (i.e. prescription or OTC)
  • Product Name (which is pretty complicated on its own)
  • Dose Form
  • Active Ingredients and their Strengths
  • Devices integrated with the product
  • Indications

Add to that the minimum items for changing a packaging ID:

  • Container Type and Materials
  • Number of items in the Container
  • Components in the Package (trays, spoons, etc.)

and it’s still pretty reasonable.  IDMP is expected to expand beyond that in order to make the effort of collecting the information currently required for Article 57 a little more acceptable by dangling a few carrots such as the possibility of using IDMP to submit minor variation changes (Europe’s “Type IA”), and other patient safety initiatives such as integrating with the Falsified Medicines Directive (which requires GTIN barcode data), and E-Prescription (which will need interactions and adverse experiences).

The main thing is that IDMP is a means of reporting your product lifecycle master data to the agencies.  It results in a number of agency benefits around patient safety, their primary mission. But the information in IDMP is valuable corporate knowledge. It’s things you already know, but may keep in separate databases, or in narrative documents such as the Summary of Product Characteristics (SmPC).  If you take a look at the IDMP data, everything falls into one of two categories:

Formulation: How the product is made, including ingredients, packaging, and the manufacturers.

Authorisation: How it is permitted to be used, including the indications, authorisation details, and what it’s called.

Every change you make, which means an updated (or new) IDMP record, means you either changed how it was made, or your authorisations for it. A few straddle the line, such as manufacturer establishment registrations. Not having this information at your fingertips in a Regulatory Information Management system can mean tracking down dozens or hundreds of documents — it’s not all in the SmPC. For example:

  • The codings for indications, contraindications and adverse experiences may only be in a labeling database
  • Batch numbers and their expiration dates will be in the QMS and ERP systems
  • The history of which sources were used for which excipients over time is only going to be in your RIM system — it might be traceable if you look at the full history of the SmPC versions, but it’ll be harder to find.
  • Which products are available for sale across all markets certainly isn’t in the SmPC — it’s the sum of all the authorisations

It all boils down to this: What you need to know about your products is a lot of the same information agencies need to know. Keep your master data accurate, current and useful and compliance with standards such as IDMP almost becomes a side effect of your own best practices.  Contact us for more information on how the ACUTA Regulatory Information Management system (ARIM) can help you manage your product registrations.

 

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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