NNIT Webinar: IDMP enforcement in Europe in 2021

This video provides a critical update on the European Medicines Agency's (EMA) Identification of Medicinal Products (IDMP) initiative, focusing on its enforcement timelines and the latest developments in the implementation guide. The speakers, regulatory affairs experts from NNIT, detail the expected publication of IDMP Implementation Guide Version 2 on February 22, 2021, which sets the mandatory go-live date for PMS (Product Management System) Iteration 1 fields for the industry by February 22, 2023. The discussion highlights the significant impact on regulatory affairs, the need for comprehensive data management and quality, and the ongoing evolution of EMA's approach to IDMP, including an agile documentation strategy and updates on substance data management.

Key Takeaways:

• Imminent IDMP Enforcement: The EMA has set a concrete timeline for IDMP enforcement, with PMS Iteration 1 becoming mandatory for industry by February 22, 2023, following the publication of Implementation Guide Version 2. This signals a definitive move towards compliance after years of delays.
• "One Side IDMP, Always IDMP" Mandate: An unofficially confirmed but critical rule states that once a company submits IDMP information for one product, all other products in its portfolio must subsequently follow suit. This eliminates the possibility of small-scale pilots and necessitates a comprehensive, portfolio-wide IDMP strategy from the outset.
• Holistic Data & Process Transformation: IDMP compliance extends beyond IT systems, requiring significant organizational effort in locating and ensuring the quality of required data, as well as fundamental changes to business processes across regulatory, commercial, and potentially clinical operations.
• Evolving Substance Data Management: The EMA is actively cleansing and synchronizing substance data through its EU SRS and SMS projects, with a focus on aligning with the FDA's GSRS. This indicates a push towards greater international harmonization in substance identification and management.
• Limitations of Standard RIM Systems: While many Regulatory Information Management (RIM) system providers are incorporating IDMP roadmaps, their solutions primarily address data model expansion and basic functionality. They often do not cover critical aspects like comprehensive data quality monitoring, integration with other enterprise systems, or the necessary adjustments to overall submission processes, highlighting the need for broader data engineering and process re-design efforts.
• Strategic Industry Preparation is Crucial: Companies must proactively prepare by staying updated on regulatory changes, mapping substances and referentials, and raising internal awareness. It's essential to plan for all product types (centralized, mutual recognition, decentralized, and national procedures) from the beginning, rather than focusing solely on centralized products.