IDMP: Why We Need It and How to Benefit

The video provides a critical analysis of the necessity and benefits of implementing the ISO IDMP (Identification of Medicinal Products) standards within the life sciences industry. The speaker establishes that the drive for IDMP compliance is rooted in two primary motivations: a business ethic imperative and a legal requirement. Ethically, IDMP aims to address a significant public health crisis, citing data from the European Medicines Agency (EMA) indicating nearly 200,000 deaths annually in the European Union due to adverse drug events. By simplifying the identification of medicinal products and facilitating faster, clearer communication about drugs and their usage, IDMP is designed to accelerate adverse event tracking and ultimately lower this mortality rate.

Legally, IDMP compliance is presented as non-negotiable for market access in the European Economic Area (EEA). The standard is a mandatory component of the new Pharmacovigilance Legislation, having been decreed by the European Commission in 2012. The speaker stresses that the question for pharmaceutical companies is not whether to adopt IDMP, but rather how to implement it, as continued market participation hinges on adherence. This regulatory push is framed as a "welcome pressure" because it forces organizations to confront and resolve deep-seated data management issues that often hinder operational efficiency and compliance.

The core internal benefit of IDMP lies in its ability to drive organizational data cleanup and structuring. The speaker notes that in most companies, critical product information is fragmented, split across various departments, systems, and locations. This fragmentation leads to basic governance failures, such as the inability to definitively identify the owner, location, or most current version of simple attributes like a medicinal product’s name. IDMP requires the collection and standardization of over 90 specific product attributes. By demanding this level of detail and structure, the standard compels companies to consolidate their knowledge, moving away from unstructured, unknown, and unreliable data sources toward a centralized, structured, known, and reliable data environment. This transformation turns a regulatory burden into a strategic asset for business intelligence and operational excellence.

Key Takeaways:

• Ethical Driver for Public Safety: IDMP is fundamentally driven by the need to reduce the high incidence of adverse drug events, estimated to cause almost 200,000 deaths annually in the European Union, by enabling quicker and more reliable identification of medicinal products.
• Mandatory Legal Requirement: Compliance with IDMP is a legal mandate under the new Pharmacovigilance Legislation, established by the European Commission in 2012, making it essential for any life science company wishing to maintain market presence in the EEA.
• Shift to Data-Centric Operations: IDMP is a major catalyst forcing the life sciences industry to transition from outdated system-centric IT approaches—where data is siloed—to a modern data-centric approach that prioritizes data integrity and standardization across the enterprise.
• Data Fragmentation Challenge: Companies struggle with basic data governance, often unable to pinpoint the exact location, current version, or responsible owner for simple product attributes (e.g., the medicinal product name), highlighting widespread internal data chaos.
• Welcome Pressure for Data Cleanup: The regulatory requirement acts as a necessary force to compel organizations to collect, consolidate, and harmonize product information that is currently scattered across different departments and legacy systems.
• Scope of Standardization: IDMP requires the rigorous standardization and structuring of more than 90 distinct attributes related to medicinal products, necessitating comprehensive data mapping and remediation projects.
• Strategic Business Benefit: Beyond compliance, the IDMP implementation process offers a critical opportunity to clean up and summarize data, transforming unstructured, unreliable information into a structured, known, and reliable data source that can be leveraged for enhanced business intelligence.
• Improved Adverse Event Tracking: Standardized identification and structured data enable regulatory bodies and companies to track any events related to pharmaceutical products much faster than was previously possible, enhancing pharmacovigilance capabilities.
• Data Ownership and Accountability: The IDMP process forces organizations to clarify data ownership and accountability for specific attributes, resolving internal confusion regarding which department (e.g., marketing, regulatory affairs, manufacturing) is responsible for maintaining the accuracy of specific data points.

Key Concepts:

• IDMP (Identification of Medicinal Products): A set of ISO standards designed to standardize the identification and exchange of information on medicinal products globally, crucial for regulatory reporting and drug safety management.
• Pharmacovigilance Legislation: The EU regulatory framework that mandates the implementation of IDMP to enhance the monitoring of drug safety and the reporting of adverse events post-market authorization.
• Data-Centric Approach: A modern IT and operational strategy that focuses on data as the central asset, ensuring its quality, accessibility, and standardization across all systems and departments, in contrast to older system-centric models where data is often trapped within specific applications.