EMA & FDA Alignment on ISO IDMP: Transforming the E2B Safety Database Landscape

The pharmaceutical industry is undergoing a seismic shift in how medicinal product data is exchanged and managed across regulatory bodies. With both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) embracing ISO IDMP standards, there are set to be profound ripple effects on E2B safety databases.

In this blog, we outline strategic considerations to keep in mind when adapting to these new ISO IDMP standards, along with how advancements in our LifeSphere MultiVigilance case management solution are making compliance simple and powering global regulatory alignment.

What Is ISO IDMP?

The International Organization for Standardization (ISO) put forward IDMP (Identification of Medicinal Products) standards as a global framework designed to harmonize the identification and exchange of medicinal product information.

ISO IDMP is a suite of five standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239, ISO 11240) that define structured data elements for medical product identification, pharmaceutical product characteristics, substance definitions, controlled vocabularies, and units of measurement.

These standards aim to enhance pharmacovigilance, regulatory reporting, and data interoperability across the global pharmacovigilance industry.

EMA, FDA Embracing ISO IDMP Standards

In a recent mandate, the EMA has required the use of ISO IDMP standards for the exchange of medical product information to enhance the quality of consistency of product data, support SPOR (Substance, Product, Organization, and Referential) reference data management, and enhance signal detection and risk management.

While the FDA has not yet mandated full-scale IDMP implementation, it is actively preparing for IDMP-driven electronic reporting. This includes developing its own IDMP code assignment system, which will soon be required in E2B(R3) submissions for adverse event reporting, Structured Product Labeling (SPL) updates, and drug establishment registration and listing.

As these global regulatory agencies and others embrace ISO IDMP standards, it is no longer a distant requirement, but a necessity to prepare for today.

What This Means for Industry Stakeholders

To remain compliant, pharmaceutical companies need to ensure that their E2B safety databases are aligned with EMA and FDA IDMP implementation timelines and data governance protocols.

This includes Life Sciences organization taking steps to:

Audit Safety databases for compliance with EMA and FDA IDMP requirements.
Engage with SPOR, FDA IDMP initiatives to obtain and validate product identifiers.
Establish flexible databases able to integrate IDMP codes from multiple authorities.
Invest in data governance frameworks that support global regulatory compliance.
Collaborate with vendors and regulators to ensure seamless integration of IDMP into pharmacovigilance workflows.
Improve traceability and data integrity in adverse event reporting.

IDMP Compliance Made Simple with LifeSphere MultiVigilance

To help Life Sciences organizations achieve stay ahead of IDMP mandates and achieve global regulatory alignment, we purpose-built our LifeSphere MultiVigilance case management solution to support the full end-to-end lifecycle of IDMP data, from structured intake to submission.

This includes:

Automated data mapping to IDMP attributes.
Real-time validation against regulatory schemas.
Seamless integration with master data systems.
Out-of-the-box Industry Standard Practices (ISPs) tailored for IDMP workflows.

Key benefits delivered include:

Accelerated Deployment – ArisGlobal’s expedited implementation model ensures faster time-to-value for IDMP readiness.
Scalable Architecture – The LifeSphere platform supports modular activation, allowing organizations to expand IDMP capabilities as needed.
User-Centric Design – A modern interface streamlines IDMP data entry and review, reducing complexity for pharmacovigilance teams.

It’s Time to Prepare for the Future of IDMP Compliance

The convergence of EMA and FDA around ISO IDMP standards marks a new era in medicinal product data management. While the transition may be complex, the long-term benefits of enhanced data quality, improved patient safety, and streamlined regulatory processes are well worth the effort.

As IDMP becomes the backbone of global pharmacovigilance, the E2B safety database is no longer just a repository – it’s a strategic asset in regulatory intelligence.

ArisGlobal is committed to supporting this evolving regulatory landscape, with LifeSphere MultiVigilance providing a Safety solution that is fully aligned with the latest ISO IDMP standards and can help you navigate the complexities and stay ahead of regulatory expectations, including EMA and FDA requirements.