Regulatory affairs as the connective tissue of pharmaceutical product data

Arguably no pharma function has as complete a picture of a medicine across its full lifecycle as Regulatory Affairs (RA). This is because RA sits at the end of every data chain, receiving compound characteristics from discovery, formulation parameters from development, quality data from manufacturing, and safety information from pharmacovigilance EM_DASH and checking it for consistency before it reaches a health authority (HA). This makes RA the natural candidate for a more strategic role that will be needed increasingly now: serving as the organisation’s primary steward of trusted product data.

As HA preferences shift from narrative-led dossiers towards structured, machine-readable submissions, any inconsistencies in information (or in the way that something is referred to) that were once absorbed into documentation will become apparent as soon as algorithms are applied to the underlying data. This in turn will draw attention to who owns and governs product information across the enterprise, something RA is best placed to address. Either way, structured submissions will force the issue.

A shared vocabulary across the enterprise

ISO IDMP provides the technical foundation for the shared vocabulary now needed (1). Its significance is not only regulatory. IDMP-compliant data carries the same meaning in a quality management system as it does in a clinical database or a pharmacovigilance (PV) platform. A substance identifier assigned to a compound during early development can follow that compound through manufacturing, labelling and adverse event reporting without being re-interpreted at each functional handover. The standard gives RA a common vocabulary to enforce consistency across functions, rather than reconciling whatever comes in for submission.

As things stand, most companies remain some distance from realising that potential. Product information is still typically held across siloed systems built for functional purposes rather than cross-system interoperability. EMA’s Product Management Service (PMS) EM_DASH the EU’s primary vehicle for IDMP implementation (replacing the legacy xEVMPD system) EM_DASH has brought immediate compliance pressure: structured data requirements for products on the Union List of Critical Medicines apply from June 2026, with further deadlines following shortly after (2). EMA has already sought formal assurances from industry associations that those deadlines will be met (3), which is itself an indication of how patchy preparation has been, generally speaking.

The cost of disconnected data

Beyond the compliance risk EM_DASH discrepancies surfacing in inspections or, equally bad, in the days before a submission deadline EM_DASH disconnected product data degrades the quality of science itself. Information generated at one stage of development and needed at another loses fidelity each time it crosses a system boundary where identifiers, conventions or ownership are not aligned.

Although integrating regulatory and PV systems might appear a straightforward data-sharing exercise, it routinely exposes how far two functions’ product data-bases have diverged through years of separate maintenance. Resolving a single discrepancy can require consequential changes across a chain of downstream systems; the number of adjacent systems affected can run into double digits. Because PV data flows into signal detection platforms and aggregate safety reporting, the implications for data integrity reach well beyond the two functions involved.

Inconsistent product data also undermines the AI investments organisations are making across regulatory intelligence, signal detection and R&D productivity. Systems fed conflicting versions of the same data point are liable either to fail outright or to begin hallucinating EM_DASH generating outputs that look plausible but are built on contradictory source material. Establishing the data architecture correctly from the start is far less costly than trying to fix it once tools are already in use.

For research teams, the same principle holds even though the regulatory horizon can seem remote. For the small number of compounds that eventually reach submission, data captured in standardised form from the outset is directly usable at later stages without expensive retrofitting. For the much larger proportion that fail, the consistently captured record remains productive long after the compound is discontinued EM_DASH raw material for identifying patterns in attrition (e.g. using AI) and informing the next generation of candidates.

Good data governance in practice

The systems capable of managing structured product data to the required standard are largely available today; what’s more likely to be lacking is the governance to use them consistently. That means data stewards EM_DASH people embedded within or closely connected to each relevant function, with sufficient data literacy to spot where the same product element exists in two different forms and to appreciate the implications downstream.

The role of ‘data steward’ is now well established in pharma, and those filling it tend to come from regulatory backgrounds rather than pure data science. Underpinning stewards’ work there needs to be a master data and master data governance strategy EM_DASH a unifying approach to regulatory information management that holds product data to a common standard, making it portable as operational requirements evolve.

The appropriate starting point with all of this is likely to vary by the type of pharma organisation. For development-focused companies, the highest-priority for data uniformity is generally between RA and PV. For generics manufacturers, aligning RA with Quality can make more sense, with manufacturing and clinical development following. Whatever the jumping off point, a staged approach EM_DASH starting at the highest-risk data handoff EM_DASH will be easier to justify and sustain than a wholesale transformation.

An important step before standardisation work begins will be to perform a review of the existing data estate. A significant proportion of historical product data will have been captured largely because it could be, not because it serves any current purpose. Clearing this out first will help reduce scope, as well as the risk of inherited inconsistencies being propagated into the new environment.

Beyond the single organisation

Regulators working from IDMP-structured submissions will be more readily able to share and compare data across agencies, with direct implications for review timelines. There are similar potential benefits for companies collaborating on combination therapies: two organisations whose product data is held to a common standard will be better able to exchange the data required of a joint development programme than those trying to reconcile incompatible databases. As combination approaches become more prevalent across oncology and other complex therapeutic areas, that interoperability will carry growing weight.

Since RA already collects and standardises product information for external submission, the extension of that role to internal data distribution EM_DASH serving every function that needs the same trusted product record in real time EM_DASH is a relatively short step (in logic, if not always in practice). Companies that make the leap will be drawing on the same IDMP infrastructure they are building for compliance, but using it for something considerably more valuable. RA functions that wait for another part of the organisation to claim the role as product data’s “connective tissue” may find the opportunity has already moved on.

References and notes

*This article builds on themes discussed in a recent life sciences industry podcast, which can be accessed in full here.

1. ISO IDMP comprises five standards: ISONONBREAKING_SPACE11615 (medicinal products), ISONONBREAKING_SPACE11616 (pharmaceutical products), ISONONBREAKING_SPACE11238 (substances), ISONONBREAKING_SPACE11239 (pharmaceutical dose forms, units of presentation, routes of administration and packaging), and ISONONBREAKING_SPACE11240 (units of measurement).
2. European Medicines Agency, Product Management Service (PMS) implementation overview, updated January 2026: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/substance-product-data-management-services
3. European Medicines Agency, EMA requests assurances from pharmaceutical industry associations on PMS compliance deadlines, September 2025: https://plm-portal.ema.europa.eu