ISO IDMP Compliance Deadline: Why Structured Data is Your Urgent Priority to Avoid Costly Delays

As the pharmaceutical industry transitions from the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) to ISO Identification of Medicinal Products (IDMP) standards, the way Marketing Authorization Holders (MAHs) submit and manage product data is set to evolve drastically. The European Medicines Agency (EMA) has made it clear that ISO IDMP compliance will be mandatory by December 2025, and for MAHs, this timeline is rapidly approaching. Now is the time to begin preparing for this shift, with a clear focus on the most critical element—structured data.

What is ISO IDMP?

ISO IDMP is an international standard designed to provide a unified approach for the identification and description of medicinal products. It covers several aspects, including substance identification, dosage forms, pharmaceutical products, and more. The goal is to create greater consistency, accuracy, and transparency in the way medicinal products are tracked and communicated across borders. In essence, it is a major step toward improving public health by ensuring the safety, efficacy, and quality of medicines worldwide.

Why is Structured Data the Core of ISO IDMP?

Structured data lies at the heart of ISO IDMP compliance, and here's why:

1. Improved Data Accuracy and Consistency: Unlike unstructured data, structured data is organized and categorized, making it easy to manage, validate, and report across regulatory platforms. ISO IDMP requires precise and standardized data fields, ensuring that product information is accurate and consistent across all submissions, ultimately reducing errors and discrepancies.
2. Streamlined Product Tracking and Lifecycle Management: Structured data provides a clear, organized framework for tracking products through their lifecycle, from development to post-market surveillance. This ensures that MAHs can efficiently manage product changes, monitor safety, and streamline regulatory reporting.
3. Enhanced Regulatory Transparency and Communication: Regulatory authorities like the EMA expect pharmaceutical companies to communicate product information more transparently and efficiently. Structured data facilitates this by allowing better integration with regulatory systems, leading to faster approvals and improved communication with authorities. It’s a game-changer in terms of speeding up regulatory submissions and simplifying complex data exchanges.
4. Facilitating Global Data Sharing: The pharmaceutical industry operates on a global scale, and structured data enables more seamless sharing of product information between different regulatory bodies across countries. This harmonization helps avoid delays, accelerates market entry, and ensures that products are correctly identified no matter where they are distributed.

The Critical Role of Data Enrichment and Review

For many MAHs, the transition to ISO IDMP represents a significant challenge. The complexity of gathering, organizing, and validating structured data can be daunting, especially if existing data sets are incomplete or inconsistent. Companies should start now by conducting a thorough review of their current data to identify gaps, inconsistencies, or outdated records. Data enrichment—ensuring that all product data meets the stringent requirements of ISO IDMP—will be critical in this preparation phase.

It's not enough to simply collect data. The key is to enrich it, ensuring that the right data is captured and structured in a way that aligns with ISO IDMP’s guidelines. For many organizations, this will involve collaboration with data management experts who specialize in migration and regulatory compliance. Engaging the right partner early on will help streamline the data transformation process, ensuring that MAHs are fully prepared for the 2025 deadline.

Why Now Is the Time to Act

While December 2025 may seem far away, the path to ISO IDMP compliance is complex. Waiting until the last minute to begin your preparations can lead to rushed processes, potential errors, and ultimately, delays in regulatory submissions. Now is the perfect time for MAHs to start aligning their data strategies with the evolving regulatory landscape.

MAHs that prioritize structured data now will reap long-term benefits, including:

• Future-proofing their regulatory submissions, ensuring compliance with evolving standards beyond 2025.
• Gaining a competitive edge by streamlining product lifecycle management and accelerating time-to-market.
• Building stronger relationships with regulatory authorities through improved transparency and communication.

Partnering for Success: How fme Can Help

At fme, we understand that structured data is the cornerstone of ISO IDMP compliance. As the industry leader in data migration, we have the expertise and tools—like our proprietary Data Migration Center to ensure your transition to ISO IDMP is seamless. Our data management solutions are designed to meet the unique needs of MAHs, enabling you to enrich, migrate, and validate your data with confidence.

Don't wait until it's too late. Start preparing today by partnering with fme to future-proof your regulatory strategy and ensure compliance with ISO IDMP standards. With structured data at the core of this transformation, you’ll be well-positioned to meet the challenges of tomorrow’s pharmaceutical landscape.

Conclusion: Structured Data is the Key to Success

As the for ISO IDMP compliance draws nearer, MAHs must act now to ensure they are fully prepared. Structured data is the most critical aspect of this compliance journey, enabling improved data accuracy, streamlined product management, and enhanced regulatory transparency. By focusing on data enrichment and migration now, you can future-proof your organization and maintain a competitive edge in the evolving pharmaceutical industry.

The clock is ticking, and the time to act is now. Embrace the power of structured data and ensure your readiness for the future of regulatory submissions.

Contact me directly at i.crone@fme.de to explore how we can work together.