EMA, IDMP, SPOR

IDMP and SPOR: EMA Plans Published

One of the biggest concerns about implementation of IDMP in Europe has been that the plans were vague, and slipped frequently. European Medicines Agency (EMA) has just published a presentation with a detailed roadmap for the SPOR project and IDMP. The IRISS Forum also posted a summary of recent activity, but it’s limited to IRISS members (if you’re not an IRISS member and you’re interested in IDMP, you’re seriously missing out: A $99/year membership gets you access to information such as this, and webinars and discussions for a lot more aspects of regulatory submission standards). Yes, this means somebody talked about IDMP Club.

The SPOR project, as I’ve described previously, is EMA’s project for master data management of the information needed for IDMP, divided into four sub-projects: Substances, Products, Organisations, and Referentials (which we usually call controlled vocabularies). Organisations and Referentials came on line last year, and EMA has opened registration for industry users and superusers who will be able to download lists, and send in updates such as new routes of administration or addresses of manufacturing plants. They currently have 178 unique company superusers, who have then added more than 50 other users at those same companies. The Organisation system currently includes the European National Competent Authorities,  human and veterinary market authorisation holders (MAH), and veterinary maximum residue level (MRL( applicants. These will need company validation and possibly updates – there are already over 100 changes requested.

Other items that have happened recently include publication of the draft Target Operating Model (the high-level workflow for SPOR-related activities), and the Referentials Management System (RMS) now encompasses and replaces everything in the older EUTCT vocabulary database. RMS and the Organisation Management System (OMS) have also been integrated into the EU Electronic Application Form (eAF).

The SPOR plan for what is to come is divided into two main periods: before relocation of the EMA offices from London to Amsterdam, and after. The ‘before’ period is essentially 2018, and there’s a lot to be done:

  • Agreement on the format for the IDMP message (Q1)
  • Drug Sponsor (investigational organisations) added to OMS (Q1)
  • Centralised and National Authorisation Procedure manufacturers added to OMS (Q3)
  • Draft Phase 1 Business Processes, Data Scope, and Migration and Validation Strategy Published (Q3/4)
  • Integration of OMS and RMS with the Common European Single Submission Portal (CESSP) and Clinical Trials (CT) portals (Q3/4)
  • Integration of RMS and OMS with the Article 57/XEVMPD databases (the predecessor to IDMP) (Q4)
  • Migration of XEVMPD data into the Product and Substance Management Systems (PMS/SMS)

That basically means the O and R portions of SPOR will be fully integrated into EMAs processes, and the rest of the plans for IDMP will be available, at least in draft form, this year. The data migration for products and substances at that point, though, is primarily for EMA use – submissions and updates by Market Authorisation Holders and Sponsors will come later. This gives the health authorities a chance to validate the migrated data.

In terms of the Substance Management System, I’ll save that for a later post, except to say that my previous understanding continues: EMA will not require (but will permit) IDMP-formatted substance records, but will do the data translation into the SMS database on behalf of the MAH/sponsor, which is what FDA does today.

The rest of the plan has a “not before” caveat in the timing, which really depends on how swiftly EMA gets back to full productivity after relocation to Amsterdam. I’ll be using “NB” in the list below.

  • User Acceptance Testing for the Product Management System (PMS) (NB 2019).
  • Finalized Implementation Guide (NB 2019).
  • Transition Period for Products and Substances begins 12 months after the final Implementation Guide (i.e. NB 2020). At this point, submissions in IDMP format may begin.
  • Enforcement Period begins 12 months after that (i.e. NB 2021). At this point all authorised human and veterinary products must have been submitted.

That last item had one of the improvements to the scope from the earliest published plans: Veterinary authorised products are now part of the Iteration 1 plan. That added a small amount of data to the requirements (mostly around ecological impact and species treated), but enables a lot more products to be tracked. There is indication, though, that registration of veterinary products will be for those newly authorised only – not a backfill of existing products.

EMA has not yet projected dates for further iterations of the SPOR system, except that Iteration 2 will include Investigational Medicinal Products, and that Iteration 3 will expand the scope of clinical particulars – which should have major prescribing safety benefits.

ACUTA will be at the DIA Regulatory Submissions, Information and Document Management Forum (RSIDM) February 5-7, 2018, in Bethesda, Maryland, at booth 310 in the exhibition hall. I will be there and happy to discuss the impact of the EMA implementation plan. Or you can always  contact ACUTA to learn more about how ARIM and ACUTA consulting can help you prepare for IDMP compliance.

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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