By Stefan Peev, Principal Advisory Consultant, NNIT
IDMP compliance in Europe has been a grey area for a while, especially in the last couple of years. The industry has faced ever-shifting timelines, endless scope iterations and subtle new requirements drip-fed by EMA.
At the heart of Europe, Swissmedic has always closely collaborated with EMA, and they have already started using parts of SPOR master data in their applications. Across the pond, FDA has published a draft PQ-CMC guidance, but a full-fledged IDMP guidance is yet to be seen.
The latest indications suggest that in early 2023 we can expect to see the US FDA communicate their current thinking regarding their implementation of IDMP, although it remains uncertain how comprehensive it will be and what similarities there will be with the European guidelines.
A sustainable approach to IDMP is needed
It is unsustainable for the industry to continue to run multi-million-dollar IDMP projects in expectation of clear requirements, firm timelines, commitments, and definitive end-goals from regulators. The ever-changing regulatory requirements for each aspect of the product lifecycle come with a growing product dataset, which is, more often than not, shared across disciplines, and buried in documents, excel spreadsheets, and custom government portals.
As with any hurdle, the industry has looked for ways to navigate around issues efficiently, practically, and with as little disruption to their business as possible. This is why data management has received so much attention in the last couple of years. While not every company has the budget or the maturity to go there, looking at one’s company’s vision, strategy, and business opportunities and utilising them to achieve compliance by design has steadily become the norm for many big pharma companies.
Digitisation is key
In times of uncertainty about legislative timelines, the impact created by the recent pandemic and the unsurmountable quantities of data available to everyone, it is only logical that the industry ought to make the leap towards digitisation. After all, knowing what you know and most importantly – knowing what you don’t know, is the first step to making informed business decisions and achieving a better understanding of your company’s products and their compliance.
Such a huge step and a paradigm shift cannot be achieved overnight, and this is why a roadmap is essential – as Lewis Caroll put it: “If you don’t know where you are going, any road will take you there!”.
- Develop your own roadmap and design your own path forward, because regulators can only offer frameworks for implementation that won’t necessarily help you address your organisational goals.
- Approach regulatory intelligence holistically – what may seem like requirements applying to one area, could in fact be much further reaching – think SPOR, for instance.
- Take small steps towards Master Data Management and Data Governance with business value in mind. Product data is a company’s shared asset, but for it to truly become that, it needs the essential foundation that Data Governance and Master Data Management can provide.
Regulators are demanding more information about products and so are healthcare professionals and patients, so the key to success is to start your data journey now, however small.
Want to learn more about how NNIT works with a sustainable approach to IDMP? Do reach out to me.
