PMS Info Day helps drive Product Data readiness
EMA, NCAs and representatives of industry gathered in Amsterdam on 16 April 2024 to review what industry and regulators must do to ensure complete and correct product data in EMA’s new medicinal product database, PMS. EMA is currently developing the Product User Interface hosted on the PLM Portal, as well as an system to system interface to enable companies to enhance their data.
date: 29/04/2024
During the event, EMA announced the data migration from XEVMPD and EMA’s internal database, SIAMED, and continuous synchronisation with PMS has been completed. This is an important milestone and means Centrally Authorised Products' (CAPs) and Nationally Authorised Products' (NAPs) data are available in PMS in ISO IDMP compatible format. This data will be viewable later this year once the viewing capabilities of the Product User Interface (PUI) and the machine-to-machine capabilities of the application programming interface (API) become available in May.
PMS data will enable key regulatory systems being developed as part of EMA’s Network Portfolio. This includes electronic application forms (eAF), regulatory procedure management (IRIS), electronic product information (ePI), the future European Shortages Monitoring Platform (ESMP) and the Antimicrobial Sales Use (ASU) platform. During the PMS info day, each system highlighted the importance PMS data to generate efficiencies and ensure effective delivery of benefits.
The needs of these systems dictate the product data requested. The immediate focus is on the data required to enable ESMP, while other systems may have additional data requests in 2025 and beyond. This iterative, step by step approach means that there will be no big bang request to complete and enhance PMS data.
Key actions highlighted for industry stakeholders during the event were:
- Marketing Authorisation Holders to start providing additional information through XEVMPD, the existing database, on:
- Pack sizes for NAPs under the union list of critical medicines (ESMP)
Deadline: February 2025 - Herbal or homeopathic products used in the variation eAF
No deadline
- Pack sizes for NAPs under the union list of critical medicines (ESMP)
- After being granted read-only access to Product UI and PMS API at the end of May 2024, MAHs should review their medicinal products in PMS in preparation for enrichment.
- As of Q4 2024, using the Product UI or PMS API, MAHs should enrich data for manufacturing business operations, structure data on pack sizes for NAPs under the union list of critical medicines (ESMP) (final deadline: December 2025).
- Mitigate impacts of missing or incorrect Substance, Organisation, Referentials mapping by reviewing substances data (SMS) and referentials data (RMS) exports and MAH organisation information in organisational data (OMS) to ensure their Products in XEVMPD do not use any of the data that is or will be made non-current. MAHs should also use replacement substances and terms whenever possible.
During the event, an NCA, AGES, shared the path towards and benefits of PMS from the perspective of a National Competent Authority. Finally, two Marketing Authorisation Holders, Merck and Roche, took the floor to share how they have created data governance to support their regulatory data needs, including IDMP and PMS.
The agenda for the event as well as the slides used are available. The recording of the event will be available shortly on the event page.
If you attended the event (online or on-site), you still have the chance to leave your feedback on Slido.com and entering the event code #PMSINFO or by using this link.