The IDMP countdown starts now: OMS / RMS onboarding will begin on the 15th December this year!

This video provides an update on the European Medicines Agency's (EMA) Identification of Medicinal Products (IDMP) implementation, specifically focusing on the SPOR (Substances, Products, Organizations, and Referentials) master data services. Anjana Pindoria, a member of EU telematics workgroups for eCTD, xEVMPD, and IDMP, recaps the October task force meeting, highlighting significant shifts and upcoming deadlines for the pharmaceutical industry. The core message emphasizes the transition towards a more value-based approach for IDMP, moving beyond its initial focus on pharmacovigilance, and the imminent operationalization of key regulatory data management components.

The speaker details three primary achievements and developments. Firstly, the IDMP scope has broadened from solely pharmacovigilance and patient safety to encompass a more value-based approach, fostering collaboration between National Competent Authorities (NCAs) and industry to create a more efficient and intelligent regulatory landscape. This signifies a move towards streamlining review submissions and approvals. Secondly, the Organization Management Service (OMS) and Referential Management Service (RMS) are now live, requiring companies to register their "super users" in December. This is a critical step for industry engagement with the new data management systems. Thirdly, the electronic application form is undergoing a significant update, with OMS data being integrated into all four forms by December, initially for optional use, but with a strong recommendation from the EMA for early familiarization.

A significant portion of the discussion is dedicated to the concept of "controlled vocabularies," which is fundamental to the successful implementation of IDMP, OMS, and RMS. Pindoria uses a relatable anecdote about ordering a salad with "aubergine" (eggplant in American English) to illustrate the critical importance of speaking a "same language" in data exchange. She explains that controlled vocabularies are predefined terms that ensure consistency, structure, and efficiency in data management. By adopting these standardized terms, the industry can achieve greater organization and efficiency in regulatory submissions and data handling, ultimately preparing for when these systems become mandatory and ensuring seamless communication across the regulatory ecosystem.

Key Takeaways:

• IDMP Scope Expansion: The IDMP initiative has evolved beyond its initial focus on pharmacovigilance and patient safety to embrace a broader, value-based approach, aiming for a more efficient and intelligent regulatory landscape through joint collaboration between National Competent Authorities (NCAs) and the industry.
• Operationalization of OMS/RMS: The Organization Management Service (OMS) and Referential Management Service (RMS) are now live, marking a critical phase in the EMA's SPOR master data services implementation. Companies must prepare for their operational use.
• Super User Registration Deadline: A key immediate action item for pharmaceutical companies is the registration of "super users" for OMS and RMS in December. This is essential for accessing and interacting with the new systems.
• Guidance for Onboarding: The EMA has provided resources, including dedicated YouTube channels and social media sites, offering step-by-step guidance on how to register super users and understand the workflow with controlled vocabularies.
• Electronic Application Form Integration: The electronic application forms are being updated to integrate OMS data across all four forms by December. While initially optional, the EMA strongly encourages early adoption and familiarization.
• Proactive Familiarization is Key: Industry stakeholders are urged to start performing searches, using the available OMS data, and familiarizing themselves with the new forms and data structures now. This proactive approach will ensure preparedness when the use of OMS data eventually becomes mandatory.
• Importance of Controlled Vocabularies: A central theme is the necessity of "controlled vocabularies"—predefined, standardized terms that ensure everyone "speaks the same language" in regulatory data. This standardization is crucial for structured, organized, and efficient data exchange.
• Benefits of Standardized Language: Adopting controlled vocabularies leads to increased organization, efficiency, and clarity in regulatory submissions and data management, reducing ambiguity and errors inherent in disparate terminology.
• Future Preparedness: Early engagement with OMS, RMS, and controlled vocabularies will position companies as "experienced experts" when these systems become mandatory, streamlining future compliance and operational processes.

Tools/Resources Mentioned:

• EMA social media sites
• EMA's dedicated YouTube channels (specifically for OMS/RMS guidance)

Key Concepts:

• IDMP (Identification of Medicinal Products): A set of ISO standards for the unique identification of medicinal products, crucial for global pharmacovigilance and regulatory activities.
• SPOR (Substances, Products, Organizations, and Referentials): The EMA's master data services, which include OMS and RMS, designed to support IDMP implementation and provide centralized, authoritative data.
• OMS (Organization Management Service): An EMA service providing master data on organizations (e.g., marketing authorization holders, manufacturers) involved in regulatory procedures.
• RMS (Referential Management Service): An EMA service providing master data on referentials (e.g., lists of countries, routes of administration, dosage forms) used in regulatory submissions.
• Controlled Vocabularies: Predefined, standardized sets of terms used to ensure consistency and interoperability in data exchange, critical for structured data management in regulatory contexts.
• NCA (National Competent Authorities): The regulatory bodies within individual EU member states responsible for overseeing medicinal products.