With the publication of EMA’s IDMP/SPOR implementation guide (V2), the transition of the ISO IDMP product data standard can be transformational.
EMA’s publication of the IDMP/SPOR implementation guide (V2) is a welcome development in the transition of the ISO IDMP product data standard to something tangible and transformational.
The new guidance is a practical anchor, enabling pharmaceutical companies targeting EU markets to move forward with plans to organize and submit product information in a standard structured data format (FHIR) alongside their eCTD documents. Within a year, aligned and simultaneous content and data submissions will go live for Centralized Procedures managed by EMA. It follows that pharma companies will want to take advantage of the intervening time to make sure they are ready and able to meet the requirements, even if these won’t be mandatory straight away.
The combined document-and-data marketing authorization submissions constitute the Target Operating Model (TOM) of EMA’s IDMP rollout. This new model – the basis of the transformation everyone is aiming for – will be a significant driver for change.
Whereas, up to now, companies have submitted their product data only once the initial document-based application or maintenance regulatory activity has been assessed and approved, almost as an afterthought, in the new IDMP-enabled scenario that data will be front and central to the authority vetting process.
Regulators will use electronic documents and the supporting data side by side to check for consistency, raise and resolve queries, and process updates. This will pave the way for much more seamless analysis of information consistency and accuracy. Boosted by AI-enabled automation, this content/data cross-analysis will enable much faster and more efficient follow-up, in theory shortening the time taken to get a product to market.
Aligning with the available advantages
To take full advantage of this transformation to regulatory processes, and to accelerate their own ways of working, pharma companies need to consolidate their data and content management capabilities so they are not doing everything twice or creating more work for their teams than is required.
Up to now, a large majority of companies have treated their post-authorization XEVMPD data submissions as a technical/administrative obligation, a tick-box exercise that could be readily outsourced to someone else. The IDMP TOM forces a change to that way of thinking, prompting companies to reinvent the way they prepare, check and manage product detail on an ongoing basis, not just for regulators but for their own internal process improvements.
To capitalize on all of this potential, Regulatory Affairs teams need to be able to cater for both structured data and document-based presentation of information as part of a single continuum based on the same master source: a single source of product truth. It must be possible both to reliably extract data from documents to complement, update or verify existing data records; and to build new contents from definitive, agreed data.
Continuing with two separate systems and processes, to meet and data submission needs respectively, will undermine any internal benefits. Companies should be aiming to compile and submit data and content submissions in the same system, now that both processes are interconnected.
Investing in data quality
Alongside the convergence of content and data creation and management activities, companies must prioritize and formalize the governance of data – as the master source from which everything else will be created in future.
This means considering who will be the data owners – those responsible for collating, verifying/quality-checking and maintaining high-grade data assets. Assets that multiple teams will assume to be correct, up-to-date and authoritative, as they build new marketing submissions and other product-related content.
The more time companies are able to take, and the more comprehensive they are in embracing the process transformation possibilities, the more they stand to gain.
Once there is strong master data to work from, there will be no need to go hunting for the latest information to input for each new registration activity. Instead, those responsible can focus on enriching and building the quality and scope of the data.
That might involve using AI-based capabilities built into their end-to-end regulatory information capabilities – to cross-check the integrity and completeness of information between data and content submissions, determining where references are out of sync and which need to be corrected.
Be clear: there are no shortcuts
While having a proper IT solution is a key success factor, none of these desirable scenarios are addressable merely by deploying a particular software package. For each company, there is much bespoke preparatory work to be done. But thorough groundwork now will set them up for the long term, lightening the administrative load forever after – as long as they continue to keep pace with evolving regulatory requirements, not just in the EU but globally.
Staying on top of the latest guidelines; knowing the baseline companies are starting from with their product information management transformations; and mapping out a logical journey to the new state are important next steps now. Whether integrated tools or a more comprehensive regulatory information management platform are identified as the most futureproof option to underpin the new ways of working, involving software vendors and consultants as partners throughout that journey will be the best way of ensuring that the chosen route is the right one – and that the particular process optimisation capabilities are optimal for the given company.
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Head of Product Management & Consulting
About the author
Agnes has been in the position of ALSS Head of Product Management and
Consulting since May 2017. Her main responsibilities are the contribution to
the development and enhancement of the Amplexor Life Sciences Suite,
supervision of the Life Sciences Consultants as well as the provision of
business process and data management expertise to Amplexor clients in
Regulatory Information Management, Document Management, and