EVMPD Becomes More Routine but Concerns Still Remain

Written by Gillian King, Head of Global Consulting, Global Professional Services, CSC Life Sciences

The months since the EudraVigilance Medicinal Product Dictionary (EVMPD) became mandatory – 2nd July, 2012 – have seen companies and the EMA begin to settle into what is required of them.

Early on, the client feedback we were receiving was that not all was as it should be. Clients were displeased about the portal they were submitting to, noting it would go down or time out. Those complaints have slowed, indicating the EMA has put some effort into the system to make sure it’s working more reliably. So while it’s still not perfect, it has improved.

Companies have now turned their attention to the next generation of data that they need to collect. A lot did the basics in the lead up to 2nd July so they could meet the intention of EVMPD; now the focus is around keeping their EVMPD obligations up to date and incorporating EVMPD data into their general regulatory information management.

The one area that has created confusion for companies concerns how quickly they have to update certain pieces of information. The EVMPD guidelines state that if there are any changes to the data, these must be submitted within 15 working days. At the moment with the reduced scope of information that has to be provided the simple rule of ‘do I need to update the SmPC? Yes, then I need to update the XEVMPD’ works well. The challenge will come when the structured substance information (SSI) is reintroduced. That’s where the issue of timing comes into the picture – some changes may be minor updates, and don’t require an approval if companies use a “do and tell” procedure once a year to inform the agency about these changes. But it does pose the question of how will the requirement to submit EVMPD changes within 15 days affect the usual way of working? Companies are wondering if they will need to do both – the EVMPD update and the annual update -- and they’re concerned they will forget or are unsure what they need to do.

Agency Silence
Though the introduction of mandatory EVMPD was a major regulatory change, the agency itself has been surprisingly quiet about what it thinks of the EVMPD data. There’s been no feedback from focus groups or industry groups about what the agency is doing with it, which leads us to believe they haven’t done anything with it. Regulators at the agency have spent all their time making sure it’s been gathered and that’s about as far as it has got.

In fact, the only communication from the agency is about the IDMP, which will likely provide comfort to companies as it’s likely that will be the next focus. Indeed, the EMA has now stated it will not be implementing the SSI in advance of IDMP and that the intent is to use the FDA’s Substance Registration System . This is a database entered by FDA experts, who compile it from information in the dossier, not from a message format. That doesn’t fit with the proposed IDMP standard but at least it gives us a migration path for the thousands of substances to be entered. This does give industry some breathing room on SSI data until the mechanism and IDMP standards are set up.