With the first “optional” submissions of IDMP data for Centrally Authorised Medicinal Products within the European Economic Area (EEA) now only a matter of months away (currently scheduled for Feb 2022), Calyx Regulatory Information Management (RIM) implementation experts are sharing their perspectives on its impacts and how sponsors can address them to reduce burdens while ensuring compliance with the new standards.
In this first installment, we talk to Darren Oakes, Manager of Regulatory Implementation at Calyx. He reflects on how IDMP builds on XEVMPD and the improvements which IDMP will bring to the capture of the data.
How does IDMP build on XEVMPD?
With the implementation of XEVMPD in 2012 the industry had its first glimpse into how structured regulatory data could be captured and submitted.
While XEVMPD met Article 57(2) of Regulation (EC) 726/2004 requirements to create and maintain a database of all authorized medicinal products for human use within the European Economic Area, its implementation ended up producing disparate versions of the same information. This caused a significant amount of effort to reconcile updates from agencies back into sponsors’ systems which were already being maintained with the life cycle of the product data.
Since then, we have seen the continued extension and evolution of requirements, ultimately leading up to where we are now with the latest updates reflecting today’s needs post-pandemic (and Brexit).
What is the lift now for sponsors as they move to IDMP?
— To enrich their existing XEVMPD data with the new data points for IDMP
— To incorporate the maintenance of these into their processes
— To look at the sources of data and integration points to avoid maintenance of multiple data sets
What do you think is the biggest impact from a data perspective?
The structure with which to capture the data in IDMP reflects the reality of how medicinal products are authorized. It doesn’t sound like much, but this is a good change for the industry. It may also provide the impetus for the industry to align and update their SmPC and other labeling documentation.
What does that mean in real terms?
Well, if I take a Centralised Product, for example, it has a registration number per package set. That means if a tablet is delivered as 2×5, 4×5 and a 6×5 blister pack, each of these packs has their own EU license number. For XEVMPD the tablet details are tracked for each of those three license numbers.
In IDMP the tablet details are tracked only once, and the three license numbers are linked to that tablet.
The challenge to duplicate the data into the XEVMPD granularity has been a pain point for years as it doesn’t reflect the regulatory processes or how clients typically track their data. The change with IDMP makes sense, as there is less duplicative data to track.
Stay tuned for future installments to this series, where Calyx RIM implementation experts review the impacts of IDMP and how sponsors can prioritize and address them to ensure their compliance with the new standards.
About the Author
Darren Oakes – Manager, Regulatory Implementation
Darren Oakes has over 20 years working within the pharmaceutical industry and brings a wealth of experience in regulatory information management (RIM). His current focus is on helping Calyx RIM clients optimize the management of their regulatory data.