The European Medicines Agency (EMA) has published a step-by-step registration guide for the beta release of its Public Product Management Service (PMS) Application Programming Interface (API), enabling authorised stakeholders to programmatically retrieve medicinal product data under the ISO IDMP standards. The document, dated 12 June 2026, outlines the prerequisites, registration steps, and access provisioning process for organisations and technical users wishing to onboard to the service. The beta release provides controlled access to selected public PMS data, allowing early integration activities and operational experience ahead of full production readiness, which EMA currently expects by the end of 2026.
The Public PMS API supports access to data managed within the Product Management Service, which forms part of the implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe. The registration process requires users to have an active EMA account on the EMA Access Management (EAM) portal, request Public PMS API access, and accept EMA's API General Terms and Conditions of Use. EMA may adjust the scope, content, and functionality of the PMS FHIR/API during the beta period and will monitor API usage and data quality.
Impact on stakeholders
Pharmaceutical companies and IT vendors developing systems to submit or retrieve medicinal product data in IDMP-compliant formats are directly affected. The beta release allows them to test integration and familiarise themselves with the API, but the document warns that data and services made available through this beta release should not be relied upon for operational, regulatory, or production use. This creates a trade-off between early access for testing and the inability to use the data for compliance or business-critical decisions until full production readiness.
National competent authorities in EU member states, which will ultimately rely on PMS data for regulatory oversight, benefit from early stakeholder testing that may improve data quality and system robustness before full deployment. However, they must wait for the production release to integrate the API into their own workflows.
EMA itself gains operational experience and feedback from beta users, enabling continuous improvement of PMS data and the API. The agency also ensures secure access through authentication and authorisation via the EAM portal, reducing security risks.
No prior coverage of this document exists in the last 180 days, so this is the first public guidance on the PMS API registration process.
← Atlas › News › Health & Lifestyle