Background and Challenges
IDMP Readiness Supported by Automation: SmPC BOT – The ISO IDMP (Identification of Medicinal Products) standard is an international standard established in response to the need for the unambiguous identification of medicinal products, primarily to improve information exchange and support pharmacovigilance activities. The general objectives of the standard are:
- Improve the exchange of information among regulatory authorities, companies, and within the same company
- Enhance drug safety monitoring
- Improving data integrity and reliability
- Streamline regulatory activities
- Support mechanisms for verifying the authenticity of medicines
The standard includes a data model with over 200 fields, designed to collect all product-related data.
To date, Europe is leading the way in adopting the standard. The EMA has set up a dedicated working group and launched the SPOR programme (Substance, Product, Organisation, Referential) to support implementation.
The adoption strategy has shifted over time. Initially envisioned as a ‘big bang’ rollout with multiple iterations, the EMA has now moved to a more gradual, agile approach. This strategy is split into several initiatives that share “the IDMP language” — such as eAF, ePI, RPM, and ESMP.
While this flexible model allows for priority and deadline adjustments, it also creates challenges. Stakeholders must continuously adapt to ongoing changes.
What are the difficulties for Companies?
One of the main challenges companies face is managing their data effectively. This includes identifying the data source, retrieving the data, aligning it with implementation guidelines, and putting in place reliable processes for ongoing management and maintenance.
Even when data exists internally, it is often stored in unstructured formats — commonly within documents like the SmPC (Summary of Product Characteristics). Although the SmPC follows a structured format with mandatory sections, the content within those sections remains unstructured. According to the Implementation Guides, part of the required IDMP data can be extracted from the SmPC, but doing so is not straightforward.
Another complication arises from the multiple EMA systems where IDMP data is reported. These systems often fall out of sync if companies do not manage IDMP submissions across EMA services using a unified, end-to-end data governance process.
Our Approach
Arithmos approach is to manage all IDMP data within the company, not relying on EMA IDMP & XEVMPD services only.
In this context, Arithmos drew on its industry experience to assess the challenges companies face when collecting IDMP data across the organization. A key issue identified is the difficulty of extracting data from documents — a problem encountered in 50–60% of cases, based on our benchmark. The manual effort required to manage this process is significant.
We focused particularly on the SmPC, as it is the document containing the most IDMP relevant data, and developed a BOT that, leveraging AI logic, is capable of:
- Reading the document
- Identifying sections with the necessary information
- Extracting the data required by the IDMP standard
- Applying data normalization, such as mapping to controlled vocabulary codes (RMS list) and formatting dates as required
Importantly, AI is not the objective in itself—Arithmos’ innovation lies in using AI as a trusted accelerator to strengthen compliant, efficient, and sustainable regulatory processes.
Success Factors and Outcome
The SmPC BOT was used in a specific project to support data entry resources, with the goal of extracting the maximum possible amount of IDMP data from the company’s provided SmPCs, aligned to IDMP specification (Implementation Guidelines v2.1)
Key results emerging from the use of automation included:
- A reduction in the time needed to retrieve normalized data against the RMS list, particularly evident for substances and therapeutic indications, saving approximately 40 minutes per SmPC on average
- Improved data quality through the correction of manual retrieval errors and typos from SmPCs
- Facilitation of identifying correct values, even when the BOT provided only partial outputs
- Adherence to the project timeline for SmPC data extraction
Technical specifications
During the pilot implementation, the BOT successfully extracted up to 93 IDMP-relevant fields per SmPC document. These included both static values and dynamic content requiring contextual interpretation or alignment with controlled vocabularies — such as full name, dosage form, therapeutic indications, ingredients, strength, route of administration, and marketing authorization data.
Each extracted value was assigned a confidence level (High, Medium, Low), which helped guide downstream data curation. This scoring system enabled targeted manual review only where necessary and provided a way to measure the BOT’s performance.
The results were promising: over 70% of fields were extracted with high confidence, requiring minimal human correction. This demonstrates the BOT’s strong baseline accuracy and its potential to significantly accelerate data extraction efforts.
Conclusion
This case study highlights Arithmos’ ability to strategically combine human expertise with automation in a way that elevates — not replaces — the quality of regulatory processes.
Arithmos is committed to continuously evolving the SmPC BOT — not to chase technology trends, but to responsibly support our clients in navigating the complexity of regulatory transformation.
Navigate Regulatory Transformation with Arithmos’ Support
About the Author
Educated as a Biomedical Engineer at Politecnico di Milano, Ilaria’s career spans in the Healthcare and Life Sciences industries, focusing on computerized systems, digitalization, and the successful delivery of complex projects.
She has extensive experience in managing complex technological projects, translating client needs into concrete digital solutions within regulated environments.
As a Senior Consultant, her expertise includes defining digital strategies, leading implementation projects for standards like IDMP to ensure compliance and optimize processes, and exploring the application of Artificial Intelligence.
Her background also includes a solid understanding of healthcare IT systems and processes, gained from his previous roles.
About Arithmos
With deep expertise in the Life Science Industry, Arithmos supports companies in their digital transformation journey to achieve the best value from technology-enabled solutions and excellence in business operations.
Arithmos team share extensive knowledge of the full GxP regulated environment for both deliveries of services and technologies, and our domains range from Clinical Development, Quality & Compliance, Pharmaco-Vigilance & Safety and, Regulatory Affairs.
