Pharmaceutical companies are under increasing pressure to deliver accurate, timely, and multilingual product information in a fully digital format. Yet without a standardized system, outdated processes and inconsistent data formats make this nearly impossible to scale or regulate effectively. That’s where structured product labeling and electronic labelling come in—offering a reliable, automated framework to meet regulatory demands and ensure high-quality electronic product information (ePI).

What is structured product labeling and how does it support ePI adoption?

If you’re wondering what is structured product labeling, it’s essential to understand that it’s not just a document format—it’s a regulatory framework. Structured Product Labeling (in US it is also called SPL) is a standardized, XML-based format developed to ensure that pharmaceutical product information is machine-readable, consistently structured, and regulatory-compliant.

SPL encodes key information such as indications, dosage, contraindications, and packaging in a structured form. This makes it easier for authorities, systems, and healthcare providers to process, validate, and publish data automatically. SPL plays a vital role in enabling electronic labelling by serving as the foundational structure for content exchange.

Service providers for transition to ePI such as Billev Pharma East help companies integrate SPL into their workflows, making it easier to transition from paper-based processes to modern digital solutions like electronic product information (ePI). By leveraging SPL, companies ensure that their product information is not only compliant but also ready for digital distribution to external stakeholders.

Billev Pharma East has been part of the EMA/HMA ePI Pilot Project since 2022, participating in testing and delivering feedback on the business process.

Why is structured product labeling critical for accurate electronic labelling and ePI?

The rise of electronic labelling and the demand for structured, up-to-date product information across Europe and countries such as US, UK, Japan, Australia, Jordan has made SPL more important than ever. The EU’s push toward electronic Product Information (ePI) requires pharmaceutical companies to adopt formats that are standardized, multilingual, and machine-readable.

This is where SPL becomes indispensable. By organizing content into XML structure, SPL ensures consistency and enables automated updates. It supports regulatory transparency and allows pharmaceutical companies to deliver real-time information to patients and healthcare professionals via digital channels.

For companies preparing for ePI adoption, understanding what structured product labeling is foundational. SPL enables automatic validation and integration with digital publishing tools, making the entire process more efficient and future-proof. At Billev Pharma East, we help companies navigate the complexities of SPL and ensure smooth adoption for regulatory compliance.

Comparing SPL and traditional labeling in the context of ePI

One of the main differences between structured product labeling and traditional methods lies in how data is managed, updated, and exchanged. Traditional product information is typically unstructured and static—often in PDF or paper format—which makes it difficult to extract, update, or repurpose content for digital platforms.

In contrast, electronic labelling powered by SPL provides a structured, machine-readable format that allows for seamless integration with digital systems, regulatory platforms, and ePI portals. This is crucial for meeting the new expectations around digital patient communication, real-time label updates, and international consistency and moving toward harmonisation across regions.

The following table outlines key differences:

By transitioning from traditional formats to SPL, pharmaceutical companies can better support the demands of electronic labelling and future ePI ecosystems.

How does SPL enhance product information accuracy and consistency?

SPL enforces a strict format that reduces human error and improves data quality. Each section of the label—such as clinical uses, dosage, administration routes, and packaging—is encoded using XML tags. This not only makes the information machine-readable but ensures it follows the same structure across all products and updates.

The result is enhanced accuracy and consistency, both of which are essential in high-risk environments like pharmaceuticals. With electronic labelling, even a small inconsistency can lead to confusion or regulatory rejection. SPL mitigates this risk by creating a single source of truth that is easy to manage, version, and validate.

This structure also facilitates reusability of content across global submissions, improving overall regulatory efficiency.

What are the core components of the SPL framework?

SPL documents consist of two main components: the header and the body. The header contains metadata such as product identifiers, manufacturer information, version control, and packaging data. The body includes the narrative content—everything from therapeutic indications to side effects and storage instructions—formatted using a well-defined XML schema.

This structured approach ensures that every part of the label is properly categorized and easily searchable. It supports downstream applications, including automated publishing and integration with health information systems, such as EHR (Electronic Health Records) and eRx (electornic Prescription system).

Understanding this breakdown is critical for organizations transitioning to electronic labelling, where structured data is no longer optional but a regulatory expectation.

How does SPL support regulatory compliance in digital labeling?

Since 2005, the FDA has mandated the use of SPL for all prescription drug labeling submissions in the United States. Later, the requirement was extended to include over-the-counter and veterinary drugs. This move was driven by the need for standardized, machine-readable data that supports faster validation and reduced errors.

In Europe, SPL is a critical enabler of ePI initiative that aim to standardize digital labeling across member states. By adopting SPL, companies can align with both U.S. and EU regulatory expectations and ensure they are ready for digital-first compliance processes.

Regulatory bodies prefer SPL because it simplifies data validation and accelerates processing times, reducing the burden on both agencies and applicants.

Key benefits of SPL for digital compliance

Adopting SPL is not only about meeting regulatory mandates—it also offers several concrete operational and strategic benefits. Below are some of the most impactful advantages of using structured product labeling for regulatory and electronic labelling purposes:

• automated validation and error detection
  SPL allows for automatic schema checks, reducing human error and regulatory rejections.
• Faster submission processing
  Structured content can be reviewed more efficiently by regulatory authorities.
• Improved label version control
  Every update is tracked through structured metadata, allowing for better audit trails.
• Cross-market reuse
  Label content modules (e.g., indications, safety info) can be reused across countries with minimal modification.
• Seamless integration with ePI
  SPL data can be directly used in FHIR-based ePI systems, enabling real-time publishing and multilingual access.
• Higher data transparency and interoperability
  Structured labels can be parsed and consumed by electronic health records and decision support systems.

By leveraging these benefits, pharmaceutical companies can position themselves not just for compliance, but for long-term digital transformation within regulatory affairs and product lifecycle management.

How do pharma teams implement SPL efficiently?

Manually authoring SPL in raw XML is time-consuming and error-prone. To overcome this, pharma teams often use automated SPL authoring platforms or partner with regulatory outsourcing providers. These tools typically include built-in validation, template support, and version control, streamlining the end-to-end process.

Automation is especially important when dealing with complex product portfolios or multiple markets. With SPL, content can be reused across submissions, and updates can be rolled out systematically—enhancing both compliance and operational efficiency.

These systems also integrate with electronic labelling tools, helping teams convert approved SPL into digital outputs like ePI or localized label versions.

What’s the role of SPL in future ePI and digital health ecosystems?

As digital transformation accelerates across life sciences, SPL stands out as a foundational technology for the future of product information. With the EU’s adoption of FHIR-based ePI standards and increased emphasis on digital health ecosystems, structured data is no longer a nice-to-have—it’s a necessity.

SPL enables label data to integrate with electronic health records (EHRs), clinical decision support tools, and patient-facing platforms. It also allows for real-time updates, localization, and personalization, making pharmaceutical information more accessible and meaningful.

By embracing structured product labeling, companies position themselves to meet the demands of the evolving digital health landscape—ensuring their data is interoperable, reliable, and ready for innovation.

Read also:

• How does e-labelling help us understand what is electronic product information?
• Implementing ePI across digital channels for better e-labelling access 

Sources: 1 – Structured Product Labeling and Structured Product Monograph Management Services – IQVIA, 2 – Structured Labeling and Product Information – Docuvera, 3 – Electronic Product Information (ePI) in the EU – European Medicines Agency Presentation, 4 – Structured Product Labeling (SPL) Overview – Health Level Seven International (HL7), 5 – Structured Product Labeling – Wikipedia, 6 – Why Pharma Teams Need to Master Structured Product Labeling – GlobalVision, 7 – SPL Implementation Guide with Validation Procedures – U.S. Food and Drug Administration (FDA), 8 – ePI Compliance Through Structured Content Authoring – Docuvera Blog.