Conference Calling: DIA EU Electronic Document Management Conference: Part 1: EVMPD and IDMP

Written by Joel Finkle, Senior Strategist, Regulatory Services Delivery

November 29th and 30th were the DIA 13th European Electronic Document Management Conference (EU EDM for short). I was privileged to be invited to speak there, and hear the latest information from regulators, sponsors and vendors (and sample Munich’s great sausages, pork shanks and schnitzels – sorry Vienna, Munich’s got you on schnitzel). I’ve got several items I’d like to report, but a couple of them are waiting for some of the presentations to be posted to the DIA website (eCTD 4 update, electronic submissions in China). So I’ll start with an update on the latest information on XEVMPD and IDMP, mainly from the presentation by Andrew Marr at the conference.

XEVMPD Update
You should know what XEVMPD is by now (eXtended EudraVigilance Medical Product Dictionary), I’ve reported on it previously, and this blog has had articles on it by Andrew Marr, Gillian King and Adam Sherlock also.

EMA estimates that 130-odd companies and another 130 affiliates are still missing from the companies’ database, meaning that those locations have not yet registered any products. There is a 2-4-week backlog on company registrations, and some companies can never seem to get registered, so this may account for some of the missing stuff. This does mean that there’s a good-sized chunk of data not yet registered with the Eudravigilance database.

There are only about 320,000 products that have been registered out of the estimated 500,000. EMA is still receiving about 2000 new registrations every day. At that rate, the backlog would take nearly two years to be filled, but I would guess there will likely be a few big deliveries.

Aside from the time to register, other issues that sponsors are reporting include the fact that there is no ‘owner’ of controlled terms that are shared, especially when it comes to substances and their translations: Company A may submit a substance and 12 translations, then the following release of the controlled vocabulary may have a different name and only 4 translations, because Company B submitted and “corrected” the same substance. EMA recognizes that this is an issue, but hasn’t provided a plan to resolve it yet.

Other issues such as maintenance of registered products and the Structured Substance Information (SSI) were also in the spotlight. (See EVMPD Becomes More Routine but Concerns Still Remain by Gill King)

IDMP Progress
In early November, the International Organization for Standardization (ISO) approved the five standards that make up Identification of Medicinal Products (IDMP): ISO 11238:2012, ISO 11239:2012, ISO 11240:2012, ISO 11615:2012 and ISO 11616:2012. This is a major step toward having this be an international standard for the registration of drug products worldwide… or at least in the ICH regions (US, Japan, Europe) and those that follow ICH (Switzerland, Canada, Australia and a few others). By having an ISO-approved standard, it is more likely that other countries may adopt the standard for their product registration systems.

Unfortunately, the hoped-for ICH implementation guide was not delivered as part of the most recent ICH meeting in San Diego in mid-November. This means that it will likely not appear until the next ICH meeting in March. The delivery of the implementation guide will tie together the HL7-developed IDMP message with the ISO standard, which only specifies the data, and not how it is delivered. That will take the IDMP standard into ICH Step 2. Regional implementation guides will need to follow from the ICH implementation guide, in particular because the ICH guide will be primarily concerned with ICH committee M5: pharmacovigilance, and other uses in other regions may change which elements of the HL7 message are required versus optional.

Implementation will be in three parts: Level 1 ICH Implementation Guide (not expected before March for Step 2), Level 2 is the HL7 message standards (it'll be based on SPL, but needs specifics for which parts are used), level 3 is regional implementation guides. Regulatory Sign Off (ICH Step 4) is expected in 2014.

Marr’s presentation also revealed a few new details of the IDMP standard: Some parts of the IDMP numbering system, specifically identifiers for Substances and Pharmaceutical Products (the consumed items) will be international IDs, applicable to all countries participating in the standard. The IDs for Medicinal Products (the sold items), Packages, and for Batches of the packaged product, will be specific to each region. That makes sense, as the Medicinal Product ID (MPID) includes registration number information, and the packaging and batch IDs are extensions to the MPID.

Substances are still up in the air: There is no message standard for them from HL7 yet. The FDA Substance Registration System, which creates UNII codes, will likely be used, but that isn't a message system: FDA experts create the database based on submissions. If that continues, it will be a load off sponsors' backs, but could create a huge backlog.

It's expected that much of the controlled vocabularies in EVMPD will be used for IDMP. But IMPD includes several things XEVMPD does not: marketing details, identification of regulatory agencies, manufacturers and establishments, packaging details, clinical particulars (AEs and contraindications as well as indications). This means that there isn’t a simple translation from XEVMPD to IDMP, it will take some work.

Stay tuned to this channel for more notes from the DIA conference.