Practical implication
PV teams need to update workflows and SOPs to incorporate the new PMS public API access protocols. This includes designing processes for monitoring user data access and ensuring compliance with the terms of use.
The EMA is launching a beta version of its Product Management Service (PMS) public API, effective from June 12, 2026. A technical overview is scheduled for July 13, 2026, where data access features will be demonstrated. Users will need to accept specific terms and conditions for access, and new access controls will be implemented for monitoring data usage.
What changed: The PMS public API beta release introduces new access controls, requiring users to accept terms and conditions. This affects how public users can access and utilize data related to medicines, emphasizing oversight on data access and monitoring.
Why it matters: These changes represent a significant shift in how pharmaceutical companies and regulatory bodies interact with the EMA's data, potentially impacting compliance and oversight processes for marketing authorization holders (MAHs) and sponsors.
Practical implication: PV teams need to update workflows and SOPs to incorporate the new PMS public API access protocols. This includes designing processes for monitoring user data access and ensuring compliance with the terms of use.
View original source
- Source: EMA - What's new
- Published at source: 2026-09-10T09:40:00.000Z
- Discovered by monitor: 2026-09-11T21:34:21.092Z
Published from the regulator source ingestion pipeline after PV impact triage.
