When presenting at the HighPoint Identification of Medicinal Products (IDMP) workshop in Geneva, Switzerland in April 2016, I compared the IDMP journey not just to any marathon, but to the Jungfrau marathon. The Jungfrau Marathon is one of the best known mountain marathons in the world, in full view of the famous Eiger, Mönch, and Jungfrau mountains in the Bernese Oberland area of the Swiss Alps.
Iteration 1 was the first section on asphalt roads and with hardly any incline due to the similarity with eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) requirements for authorized medicinal products. Iteration 2 was the second section with more hiking trails and some incline given the less rigorous management of investigational medicinal product data. Iteration 3 was the short section of hiking paths and with a steep incline due to the small amount of clinical particulars data requiring interpretation and coding. And lastly, Iteration 4 was the last long steep section on the hiking trails and mountain paths up to 2,100 meters above sea level due to the vast amount of manufacturing and supply chain data including operational batch information previously not submitted to the regulators.
A lot has happened since April 2016. One of the key developments has been that IDMP has been transformed from a marathon to a relay race. What does this mean? Due to multiple delays and long implementation timelines, there have been significant changes within the task force driving IDMP forward, both on the regulation and industry side; the baton has been passed. Furthermore, within industry, many organizations did IDMP assessments and planning in 2015 – 2017. With Brexit and the additional delays, many organizations either put IDMP on hold or transformed the projects from being IDMP projects to Regulatory Information Management (RIM) or Regulatory Transformation projects aiming to deliver increased efficiency and compliance along with the foundation for IDMP compliance. In practice, this means that for many companies the baton will have to be picked up by a new team, once the IDMP projects are re-started.
When to restart?
If you are in an organization that had an IDMP project and had put it on hold, you may be asking yourself, given all the delays, when is the right time to restart? The answer to that question depends on a number of factors:
- How much preparation did you already do?
- How new is the team?
- How much change have you had in data sources and related business processes?
- Progress of various IDMP-related regulator-driven projects and initiatives?
- How up-to-date is your organization on those initiatives (see below)?
Considering the current status of these initiatives, the plan for European Medicines Agency (EMA) to release their first draft of the iteration 1 guideline in an industry review by Q1 2019, and the increased certainty of EMA capacity following the relocation to Amsterdam, planning to restart your IDMP initiative early Q2 2019 seems prudent.
What to focus on?
There is no simple answer, however, suggestions, here, based on our experience:
- Conduct or update IDMP data gap assessment
- Define or update IDMP data governance
- Identify the need for data remediation in existing systems
- Define and select IDMP solution
You may have done some of this work already, therefore, you may only have to revisit and refine what’s already been done, as opposed to starting from scratch. If you would like to engage in conversation specifically about your situation and how to best to move forward, we would be happy to discuss and share our experiences with IDMP over the last four years.