How ISO IDMP Enhances Regulatory Compliance and Pharmacovigilance in the EU

The ISO IDMP (Identification of Medicinal Products) standards are revolutionizing the way medicinal products are identified and managed across Europe. Designed to streamline regulatory processes and improve pharmacovigilance, the implementation of these standards is gaining momentum within the European Union. This article explores the ISO IDMP implementation process, the strategic phased approach introduced by the European Medicines Agency (EMA), and the associated challenges and benefits for companies working to align with evolving compliance expectations.

The EMA has adopted a structured, phased implementation strategy for ISO IDMP through the SPOR (Substance, Product, Organization, Referential) Master Data framework. This framework includes several interconnected services: the Organization Management Services (OMS), operational since 2018, stores validated data on organizations involved in regulatory activities. The Referential Management Service (RMS) provides essential controlled vocabularies that standardize key product attributes. The Substance Management Service (SMS) focuses on identifying unique ingredients and materials, while the Product Management Service (PMS) acts as a centralized database for all medicinal product data.

To comply with ISO IDMP standards, companies must undergo significant internal preparation. This includes collecting and mapping existing product information against IDMP standards, which often reveal data gaps and inconsistencies. Companies also need to invest in technological upgrades to support the new data models. Establishing reliable integration with EMA’s centralized platforms is critical, as is ensuring staff are well-trained in the new systems and processes. A strong focus on maintaining consistent product information across all regulatory submissions is essential for ongoing compliance.

The EMA’s ongoing updates to its regulatory platforms and data migration processes play a central role in this transformation. Data from legacy systems such as SIMED and XEVMPD is being migrated to PMS in order to ensure long-term data integrity and usability. Additionally, the EMA continues to enhance platforms like PMS and the Extended EudraVigilance Product Report Message (EIF), further supporting both regulatory activities and pharmacovigilance efforts.

Despite the advantages, the ISO IDMP rollout does present some challenges. Data is often siloed across departments, making it difficult to consolidate and standardize. Older legacy systems can be incompatible with new IDMP-compatible models, posing integration difficulties. Moreover, ensuring the completeness and accuracy of data remains an ongoing concern, as high data quality is critical for regulatory decision-making.

Nonetheless, the benefits of ISO IDMP implementation are substantial. Enhanced pharmacovigilance is one of the most important outcomes, as standardized data enables better signal detection, improves cross-border safety monitoring, and reduces the risk of misattributing adverse events. Regulatory processes also become more streamlined, thanks to consistent and structured product information. Most importantly, ISO IDMP allows for more accurate product identification, which is vital for safeguarding patient safety.

The primary goal of ISO IDMP is to improve patient safety through enhanced pharmacovigilance and more efficient regulatory processes. As companies transition to these new standards, success will hinge on a commitment to data quality, robust system integration, and ongoing team education. This journey is not only about regulatory compliance; it represents a broader shift in how pharmaceutical data is managed and leveraged.

 

Conclusion

In conclusion, organizations that successfully implement ISO IDMP will not only fulfil their compliance obligations but also gain a strategic advantage through improved operational efficiency and data transparency. Embracing ISO IDMP is a forward-thinking move that aligns regulatory rigor with the overarching goal of better patient care.

 

How PrimeVigilance Can Help

PrimeVigilance supports companies in aligning with ISO IDMP standards by offering expert guidance on data preparation, system integration, and regulatory compliance. We help close data gaps, ensure smooth platform migrations, and enhance data quality to meet EMA’s SPOR framework requirements.

Our end-to-end pharmacovigilance services leverage standardized product data to improve signal detection, streamline reporting, and strengthen patient safety.

Contact PrimeVigilance today to discuss how we can support your organization’s pharmacovigilance needs.