XEVMPD Information session: Industry Webinar

This webinar, hosted by the European Medicines Agency (EMA), provides a comprehensive overview of the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), detailing regulatory requirements, submission processes, data quality management, and the future integration with the Product Management Service (PMs) and Data Acquisition and Data Integration (DADI) systems. The primary goal is to ensure Marketing Authorization Holders (MAHs) and clinical trial sponsors understand their obligations under Article 57(II) and CT3 Regulation to maintain accurate, up-to-date medicinal product data, which is crucial as XEVMPD data is consumed by numerous downstream processes and systems, including EudraVigilance (EV), the Clinical Trial Information System (CTIS), pharmacovigilance fee calculation, and regulatory procedures like referrals and PUSRs.

The presentation meticulously outlines the pre-submission requirements, emphasizing that MAHs and sponsors must be registered in the Organization Management Services (OMS) and EudraVigilance, with the Qualified Person for Pharmacovigilance (QPPV) registered under the headquarter profile. Crucially, at least one person from each organization must complete the mandatory XEVMPD training course and receive a successful completion certificate, achievable through either e-learning or virtual face-to-face training. Submissions of authorized medicinal products (AMPs) and development medicinal products (DMPs) must be made electronically using the XEVPRM format, either via the user interface (Web Trader) or system-to-system communication (Gateway).

Specific regulatory timelines are enforced for MAHs: newly authorized medicinal products must be submitted within 15 calendar days of authorization, and amendments following regulatory procedures (variations, transfers, renewals) must be submitted within 30 calendar days. The EMA data stewardship team performs both technical validation (confirmed via XEVPRM acknowledgment) and content validation (within two weeks for new AMPs), standardizing data based on regulatory documents like the SmPC. Data quality management is a continuous process, involving regular compliance checks for centrally authorized products (CAPs) and follow-up communications to MAHs regarding missing attachments or invalid QPPV information. For sponsors, DMPs must be submitted before completing the clinical trial application form, ensuring the EV code is available for use in CTIS, although DMP data remains confidential until the CT application is submitted.

Looking toward the future, the EMA is actively preparing for the transition to the IDMP (Identification of Medicinal Products) standards through the integration of XEVMPD data into PMs, which will subsequently feed the DADI variation form. This synchronization is planned for the end of Q1 2023, enabling the reuse of XEVMPD data for regulatory submissions. Key updates include the introduction of new legal basis and authorization procedure values to support the voluntary submission of products outside the scope of Article 57(II) (e.g., emergency use, compassionate use) and plans to introduce a new authorization status for pending products to facilitate the mandatory use of the DADI variation form by September 2023. Furthermore, the EMA is transitioning its customer support from Service Desk to ServiceNow, providing defined service level agreements (SLAs) for managing incidents, requests, and questions related to XEVMPD data and systems.

Key Takeaways:

• Mandatory Training and Registration: MAHs and sponsors must ensure their QPPV is registered in OMS and EudraVigilance, and staff responsible for submissions must complete the XEVMPD training course and obtain certification, which is assigned to the individual, not the company.
• Strict Submission Timelines: New AMP submissions are mandatory within 15 calendar days of authorization, while updates following regulatory changes (variations, transfers) must be submitted within 30 calendar days. Failure to adhere to these timelines can result in investigations or audits by National Competent Authorities (NCAs).
• Data Validation and Quality Control: New AMP submissions undergo a two-step validation process: technical validation (XEVPRM acknowledgment) followed by content validation by EMA data stewards, typically within two weeks. MAHs receive a third-level acknowledgment detailing any changes made during validation.
• DMP Submission for CTIS Integration: Sponsors must submit development medicinal product (DMP) information to XEVMPD before filing the clinical trial application (CTA) to obtain the necessary EV code for use in CTIS. DMP data is treated as confidential until the CTA is submitted.
• XEVMPD/PMs/DADI Synchronization: XEVMPD data will be migrated to the PMs database by the end of Q1 2023, supporting the DADI variation form. Any changes made in XEVMPD are expected to be propagated to PMs and DADI in near real-time (10-30 minutes).
• Data Correction Protocol: If data appears incorrect in the DADI portal but is correct in XEVMPD, MAHs must raise a ticket with the EMA to fix the underlying data mappings. If the data is incorrect in XEVMPD, MAHs must submit an update to XEVMPD, which will then synchronize with PMs/DADI.
• Voluntary Submissions for DADI Use: Products out of scope of Article 57(II) (e.g., herbal, homeopathic, products under emergency use) can be voluntarily submitted to XEVMPD if the MAH intends to use the DADI variation form for them.
• Future Regulatory Status for Pending Products: The EMA is developing a new authorization status for products that are not yet authorized (e.g., during the national phase of MRP/DCP) but require use of the DADI variation form, expected before September 2023.
• ServiceNow Transition: All XEVMPD support (incidents, requests, questions) is transitioning from Service Desk/Jira to the new ServiceNow platform, with defined SLAs (e.g., 5 working days for incidents/requests). Users must use personal EMA accounts for login due to mandatory multi-factor authentication.
• Controlled Vocabulary Changes: From January 2023, the EMA will discontinue publishing quarterly controlled vocabulary lists (substances, organizations, referential terms) on the guidance page; users must download these lists directly from the respective management services (SMS, OMS, RMS).
• Data Quality Insights: Data quality audits show high accuracy, with only 3% of validated records containing errors. Most common errors relate to the subjective data element of therapeutic indications.

Tools/Resources Mentioned:

• XEVMPD (Extended EudraVigilance Medicinal Product Dictionary): EMA database for medicinal product information.
• XEVPRM (Extended EudraVigilance Product Report Message): Electronic format used for submitting data to XEVMPD.
• OMS (Organization Management Services): Used for registering organizations and MA holders.
• EudraVigilance (EV): Pharmacovigilance database connected to XEVMPD.
• CTIS (Clinical Trial Information System): Uses XEVMPD data to identify medicinal products in clinical trials.
• PMs (Product Management Service): Future system component based on IDMP standards, fed by XEVMPD data.
• DADI (Data Acquisition and Data Integration): Platform hosting the variation form that will consume PMs data.
• ServiceNow: New platform replacing the EMA Service Desk for customer support and ticket management.
• EV Web Trader/Gateway: Methods for electronic data submission.

Key Concepts:

• AMP (Authorized Medicinal Product): Products authorized for human use in the EU/EEA.
• DMP (Development Medicinal Product): Products used in clinical trials, submitted by sponsors.
• Article 57(II): Legal obligation requiring MAHs to submit and maintain medicinal product data in XEVMPD.
• CAP (Centrally Authorized Product): Products authorized via the centralized procedure, subject to specific compliance checks.
• QPPV (Qualified Person for Pharmacovigilance): Responsible person whose information must be correctly referenced in the AMP entry.
• IDMP (Identification of Medicinal Products): Global ISO standards for the unique identification of medicinal products, driving the PMs/DADI implementation.