The EMA's first implementation guide for ISO IDMP is out now and the countdown to compliance has begun. Find out how you should prepare for this new global regulatory standard.
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The EMA is progressing its ISO IDMP (the global standard for Identification of Medicinal Products) agenda with the first full implementation guide, which is out now for consultation, to be followed by a second actionable version by next year.
For those Life Sciences firms that have put preparation for ISO IDMP on hold over the last 1-2 years, the clock is ticking.
Time for Action
Some larger multinationals that continued to evolve their IDMP plans despite shifting timelines now have proof-of-concept projects to build on, which others have a chance to learn from. In the most advanced scenarios, firms are looking to the high-quality master data sets they are working towards as the basis for process automation - for pre-filling regulatory submissions, for instance – with the potential for substantial efficiency gains, cost containment, and risk reduction benefits.
Smaller organizations, meanwhile, have tended to take a more reactive approach – focusing on other priorities until much nearer the go-live date. Although this wait-and-see attitude isn’t recommended, these companies could gain some advantage now – borrowing the conclusions of those who’ve considered IDMP compliance considerations from all angles, added to learnings from earlier experiences with IDMP’s predecessors, xEVMPD and - before that - eCTD.
The encouraging signs are that the messages about investing time and effort in establishing robust master data seem to have been heeded. Most organizations that have put serious thought into IDMP preparations are now planning to maximize the data assets they must now build, by making sure they will be compiled in a readily reusable form.
The availability of formal implementation guidelines will finally give the industry something tangible to work with, beyond the IDMP data standards that have been drip-fed to the market in recent years under different category headings.
Harnessing the broader intentions of IDMP – greater data quality, instant traceability, and so on – offers Life Sciences organizations so much more than regulatory conformance. Additionally, it provides the basis for improved end-to-end visibility across products and their lifecycle, transformation of global labeling and management of translations, and so much more.
Building Strong Foundations
In advanced master data management scenarios, which AMPLEXOR has dubbed MDM 2.0, companies are able to turn definitive, centralized product information into tangible business value by transforming the way teams create important, routine documents. It is not unthinkable to expect document authoring automation rates of 90%+, paving the way for a 10-fold acceleration in preparing regulatory submissions and patient-facing materials. All of which reduces costs, and risk of error, while substantially improving speed to market.
Creating an IDMP strategy with master data at the center is about creating something much bigger and more broadly applicable than IDMP. It involves investing in and building an agreed, single version of product truth with the potential to inform and be repurposed ad infinitum for numerous use cases.
It is from this standpoint that companies are able to entertain plans for smarter document management, including structured authoring. Here, approved ‘fragments’ of content can be called up automatically and pulled into specific documents using smart templates, orchestrated by strict workflow rules that teams can control.
Introducing AI-enabled Analytics and Automation
Once firms have established rich, reliable master data resources, they have a chance to enhance them further with value-added, contextual information (about country-specific requirements, or a product’s global status across its lifecycle) which will more directly serve internal business agendas and enable desirable process improvements.
Initiatives such as ISO IDMP are enforcing this kind of structure on pharmaceutical data for the first time, which could be the start of a new era of unprecedented data-based insights. Add artificial intelligence and powerful, large-scale data analytics into the mix, and it becomes easier and faster to search for new patterns and discoveries that might once have been impossible to detect.
A further benefit for companies that put in the groundwork now is that they will have a head start when other geographical regions start to mandate IDMP-based requirements too, the US being expected to follow Europe before long. Certainly, more holistic data reporting and real-time product transparency is the way global market requirements are heading.
You have until 2021, are you ready for ISO IDMP?
To learn more about what you need to get into compliance, click here.
About the author
Siniša is a Senior Life Sciences Consultant within Product Management team. He applies his detailed knowledge of pharmaceutical processes and documentation to the areas of business process analysis, optimization of software solutions and demonstration of their capabilities. He started his professional career at Pliva (now the TEVA Group), where in addition to his responsibilities in manufacturing, he engaged in a successful EDMS implementation project. He later joined KRKA’s Regulatory Affairs Department, and finally moved to AMPLEXOR in 2008. Siniša received his Bachelor of Science degree in Pharmacy from Zagreb University.