As of Wednesday 30th June, an updated release of the EU’s IDMP Implementation guide v2.1 is now available from the European Medicines Agency (EMA) – the next step towards the implementation of ISO IDMP in Europe and initially for the Centralized Procedure.
Although v2.0, published in February, was a solid, stable release – giving software vendors and life sciences organizations something tangible to work with in their next IDMP preparations – there are some subtle changes in v 2.1 which companies need to be aware of and plan for.
Here’s a quick summary:
1. The data elements are changing to a degree to align with the EMA Digital Application Dataset Integration (DADI) project.
Our view is it makes good sense to resolve this alignment now, allowing companies to tie their IDMP-formatted product data to this new regulatory submissions procedure. It will save issues arising later, such as the loss of certain data elements.
2. There is provision for use of structured data to report on medicines shortages at a European level for the duration of crisis situations (e.g. current pandemic), allowing more control over emerging issues.
As Covid continues to affect product availability, EMA has a greater mandate to capture information about shortages across Europe. We think it makes sense to capture this centrally, since the whole point of a European database is to be a central coordination point, into which individual National Competent Authorities (NCAs) can connect for the latest insights. We see this process being applicable for emergency situations only however; not as a means to regulate the market.
A stitch in time
The release of the updated Implementation Guide demonstrates the progress and tie in with business value data, which will add value to the PMS database on the necessity to implement a process that enables one single source of truth for all stakeholders.
We’re encouraged that things are continuing to progress with IDMP. This latest guidance update is only a week behind schedule, with a next update due in October. At that point we expect to have more information about the expected and potential use of IDMP data and it’s related process, including supporting examples and details of how to prepare and submit data.
Get the lowdown: new webinar – July 5th
For a more detailed look at the latest guidance and the changes introduced in v2.1, Iperion is running a short webinar on Monday 5th July to walk through the implications.
Attendees will learn all about the recent changes in chapters 2, 3 and 8 of the Implementation Guide; which additional data elements companies will need to collect; and processes that will need to be reviewed to achieve compliance – with some concrete next steps.
See the timing of the webinar in your local market, and sign up for the session here: https://register.gotowebinar.com/register/2890906756305307662