Webinar: “Towards a Smooth Transition to ISO IDMP”

This webinar provides an in-depth exploration of the transition to ISO IDMP (Identification of Medicinal Products) within the pharmaceutical industry, specifically focusing on the European Medicines Agency's (EMA) implementation strategy. The speakers, Ramon Hernandez and Lidia Canovas from Asphalion, begin by establishing the critical need for global standardization in defining and identifying medicinal products, moving beyond the current xEVMPD (External Vigilance Medicinal Product Dictionary) system. They introduce ISO IDMP as a series of global ISO standards that define product identification at various levels, from substances to the final medicinal product and even batches.

The presentation delves into the foundational components of EMA's IDMP approach, primarily the SPOR portal, which comprises four master data services: Substances (SMS), Organizations (OMS), Referentials (RMS), and the future Product Master Services (PMS). A significant portion of the discussion is dedicated to the historical timeline of xEVMPD, its mandatory implementation in 2012, and the subsequent delays in ISO IDMP's rollout, attributed to factors like standard finalization and Brexit. The speakers highlight the release of the European Implementation Guidance (EIG) version 2.0 in February of the current year as the critical trigger for actual implementation deadlines. They illustrate the dramatic increase in data granularity required by IDMP, using the example of packaging information, which transforms from a simple text field in xEVMPD to a complex, structured object with multiple defined attributes in PMS.

The webinar outlines a four-step implementation strategy for Marketing Authorization Holders (MAHs): understanding EMA's data requirements, assessing internal data availability and quality, defining internal processes and updating SOPs, and finally, strategizing to go "beyond compliance." The speakers emphasize that IDMP is not solely a regulatory affairs concern but a company-wide data management project requiring significant IT involvement and cross-departmental collaboration. They discuss the EMA's phased implementation plan, including the "Go-Live" for optional PMS submissions, followed by mandatory reporting for centralized and then non-centralized products. The process of data migration from xEVMPD to PMS by EMA is explained, along with the concept of "delta import" and "feedback loop" to maintain data synchronization. Practical case studies for companies with varying portfolio sizes and existing RIM (Regulatory Information Management) systems are presented, underscoring the need for tailored strategies, data audits, and potential system upgrades or new implementations to handle the new "Fire message" (FHIR standard) submissions.

Key Takeaways:

• ISO IDMP Standardization: ISO IDMP is a global initiative to standardize the identification of medicinal products, driven by ISO standards, and implemented in Europe through the EMA's European Implementation Guidance (EIG). This aims to create a unified, machine-readable definition of products across global pharma.
• SPOR as the Foundation: EMA's SPOR portal is central to IDMP, comprising four master data services: SMS (Substance Management Service), OMS (Organization Management Service), RMS (Referential Management Service), and PMS (Product Master Services), which will be the new IDMP-compliant product database.
• Increased Data Granularity: The transition to IDMP necessitates a significantly higher level of data granularity compared to xEVMPD. A prime example is packaging information, which evolves from a single descriptive text field to multiple structured objects defining materials, pack sizes, and unique identifiers (PCID).
• Phased EMA Implementation: EMA's IDMP rollout is phased, with a "Go-Live" for optional PMS submissions (not before Feb 2022, as per the webinar's timeline, implying later in real-time), followed by mandatory reporting for centralized products (not before Feb 2023, implying later), and eventually for non-centralized products.
• Comprehensive Implementation Steps: Companies must follow a structured approach: 1) Thoroughly understand EMA's data requirements from the EIG v2.0, 2) Conduct a gap analysis and data audit of existing internal data, 3) Redefine and update internal processes, SOPs, and data ownership, and 4) Develop a strategic approach that goes beyond mere compliance.
• Addressing Data Silos: A major challenge is overcoming internal data silos, where product information is scattered across various departments (e.g., regulatory, marketing, production) and disparate systems (e.g., common databases, individual Excel files), leading to inefficiencies and data quality issues.
• FHIR Message Submissions: The new standard for communicating product information to EMA's PMS will be the "Fire message" (based on the FHIR standard), replacing the XML format used for xEVMPD submissions.
• EMA Data Migration & Enrichment: EMA will migrate existing xEVMPD data to PMS, but MAHs will be responsible for significant "enrichment" by providing the extensive new data fields required by IDMP that were not part of xEVMPD.
• Impact of xEVMPD Data Discrepancies: The current xEVMPD "acknowledgement" process, where EMA can unilaterally alter submitted data, highlights existing data misalignment between industry and agency. These discrepancies will carry over to PMS if not proactively addressed through data reconciliation.
• Strategic Opportunity for RIM Systems: Implementing or upgrading a Regulatory Information Management (RIM) system is presented as a strategic opportunity to consolidate all regulatory data, streamline workflows, and ensure IDMP compliance, offering benefits beyond basic regulatory adherence.
• Company-Wide Project: IDMP implementation is not confined to regulatory affairs; it's a significant, company-wide data management and IT project requiring substantial time, investment, and cross-functional collaboration.
• Tailored Implementation Strategies: Companies, especially those with large portfolios or without existing RIM systems, need to define specific strategies, which may include phased implementation (e.g., focusing on centralized products first), data migration plans, and decisions on whether to acquire new systems or enhance existing ones.
• External Support Options: For companies lacking internal resources or expertise, externalizing services for PMS submission file preparation and SPOR maintenance is a viable option to ensure compliance and smooth transition.
• Streamlined Administrative Changes: In the future, certain administrative variations (e.g., changes in manufacturer name or QPPV location) might be directly reported to PMS without requiring a full regulatory assessment, potentially reducing the administrative burden.

Tools/Resources Mentioned:

• ISO Standards: The foundational international standards for IDMP.
• EMA's European Implementation Guidance (EIG): Specifically versions 2.0 and the anticipated 3.0, which detail EMA's approach to IDMP in Europe.
• SPOR Portal: EMA's master data management portal for IDMP, encompassing SMS, OMS, RMS, and PMS.
• PMS (Product Master Services): The future IDMP-compliant database at EMA.
• xEVMPD (External Vigilance Medicinal Product Dictionary): EMA's current database for Article 57 data.
• FHIR (Fast Healthcare Interoperability Resources): The standard for the new "Fire messages" used for submissions to PMS.
• eCTD (Electronic Common Technical Document): The format for regulatory submissions that will incorporate Fire messages.
• RIM System (Regulatory Information Management System): A key software solution for managing regulatory data and processes.

Key Concepts:

• ISO IDMP (Identification of Medicinal Products): A set of five international ISO standards defining how medicinal products should be identified and described globally, covering substances, pharmaceutical products, medicinal products, units of measurement, and controlled vocabularies.
• xEVMPD (External Vigilance Medicinal Product Dictionary): The current EMA database (also known as the Article 57 database) that stores structured data about authorized medicinal products for pharmacovigilance and other regulatory activities.
• SPOR (Substances, Products, Organizations, Referentials): EMA's master data management system designed to support IDMP implementation, providing centralized, authoritative sources for key regulatory data.
• PMS (Product Master Services): The future component of SPOR that will serve as EMA's central database for IDMP-compliant medicinal product data, replacing xEVMPD.
• Fire Message (FHIR): A standard for exchanging healthcare information electronically, adopted by EMA for submitting IDMP-compliant product data to PMS.
• EIG (European Implementation Guidance): A document published by EMA that translates the global ISO IDMP standards into specific requirements and processes for implementation within the European Union.
• Delta Import & Feedback Loop: Mechanisms during the IDMP transition period to ensure data synchronization between the existing xEVMPD database and the new PMS, allowing updates in one system to be reflected in the other.
• Regulatory Information Management (RIM) System: An integrated software solution used by pharmaceutical companies to manage all aspects of their regulatory information, including product registrations, submissions, compliance, and master data.

Examples/Case Studies:

• Packaging Data Transformation: The webinar provided a detailed illustration of how a single "package description" text field in xEVMPD, containing free-text information about pack sizes and materials, will be replaced by a highly structured, object-oriented data model in IDMP. This new model requires defining separate objects for the box, blister, and manufacturer item (e.g., tablet), specifying materials, quantities, and generating unique identifiers (PCID) for each pack size.
• Siloed Data Management: The speakers highlighted a common industry challenge where different departments (e.g., regulatory, marketing, production) and even individuals within those departments maintain product data in disparate systems, such as shared databases, individual Excel files, or documents. This fragmentation leads to difficulties in data access, quality, and timely updates, making IDMP compliance more arduous.
• Streamlining Administrative Variations: An example was given of how IDMP might streamline certain administrative changes, such as a change in the Qualified Person for Pharmacovigilance (QPPV) location or a manufacturer's name. In the future, these might be directly reported to PMS via a Fire message without requiring a full regulatory assessment and eCTD submission, reducing the procedural burden on MAHs.