How DrugCard Delivered Reference SmPC Change Monitoring in Just 1.5 Months

Speed and precision are critical requirements in regulatory and pharmacovigilance processes. Every update to a reference product’s SmPC can directly impact patient safety, regulatory compliance, and a company’s market position. Yet, despite this importance, many pharmaceutical companies still rely on manual, fragmented processes to track these changes. That is precisely where Reference SmPC change monitoring becomes essential.

This is also where DrugCard chose to listen, act, and deliver.

The Growing Challenge of Reference SmPC Changes

For companies marketing generic, hybrid, or biosimilar medicines, the Reference SmPC is the regulatory gold standard. Any change in the safety information, indications, warnings, or dosing of the reference product must be identified and assessed. After that, corresponding updates must be implemented in the company’s own SmPCs.

In reality, this process is far from simple.

Regulatory and pharmacovigilance teams often need to manually check the Ukrainian State Register of Medicines, download new SmPC versions, compare them with previous documents, and try to detect what has changed. Moreover, this work must be repeated continuously for multiple reference products.

As a result, Reference SmPC change monitoring becomes slow, error-prone, and resource-intensive.

Eventually, several DrugCard clients raised exactly this concern.

From Client Pain to Product Priority

Instead of treating the request as a minor feature suggestion, DrugCard specialists took a different approach. They worked closely with clients to gain a clear understanding of how Reference SmPC change monitoring is carried out in everyday regulatory workflows.

By observing teams in action, they learned the challenges of locating new SmPC versions and comparing lengthy regulatory documents line by line. They also recognised the potential consequences of overlooking a critical update, which could later lead to audit findings or regulatory penalties.

Based on these real-world workflows, DrugCard translated client needs into a clear development roadmap.

A Fully Automated Solution in Just 1.5 months

Within just one and a half months, DrugCard released a new automated module for monitoring changes to the Reference SmPC.

The solution is directly integrated with the Ukrainian State Register of Medicines. It automatically detects new SmPC versions for reference products as soon as they appear. Furthermore, the system compares the new document with the previous version and highlights all textual changes that have been made.

As a result, regulatory and PV professionals can immediately see what was updated, where the change occurred, and how significant it may be.

Instead of manually searching, downloading, and comparing files, teams now review SmPC changes in minutes.

Why Do This Changes Regulatory Workflows

This new approach to Reference SmPC change monitoring does more than save time. It fundamentally reduces regulatory risk.

When changes are automatically detected and visually highlighted, nothing gets overlooked. Teams no longer depend on memory, spreadsheets, or manual tracking. At the same time, documentation becomes easier to prepare for audits, inspections, and internal quality reviews.

Moreover, faster detection means faster action. Companies can initiate variations and safety updates sooner, thereby protecting both patients and ensuring regulatory compliance.

A Rare Example of True Customer-driven Development

In many pharmaceutical IT systems, development cycles are slow and disconnected from the real needs of users. However, this DrugCard case presents a distinct scenario.

Clients described a regulatory pain point. DrugCard prioritised it. The platform delivered a working, production-ready solution in under two months.

That level of responsiveness is still rare in pharmacovigilance technology.

The Future of Reference SmPC Change Monitoring

With this new functionality, DrugCard turns a complex regulatory obligation into a streamlined, controlled, and auditable process.

Companies no longer have to chase SmPC updates. Instead, the updates come to them, already analysed and clearly displayed.

That is what modern Reference SmPC change monitoring should look like.

In pharmacovigilance, companies that stay compliant are not those who work harder, but those who work smarter.