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EMA Releases FHIR-Based API Implementation Guide

EMA Write PMS API implementation Guide | GMP Platform GMP

The European Medicines Agency (EMA) released an implementation guide for the Pharmacovigilance (PMS) API, utilizing FHIR standards.

August 13, 2025EMA

Summary

The European Medicines Agency (EMA) has released the "Write PMS API implementation Guide" based on FHIR. This guide is a comprehensive toolkit designed to ensure efficient and secure exchange of medical data by adhering to the FHIR standard.

Key Players

EMAGMP Platform

Details

The European Medicines Agency (EMA) issued a document titled "EMA Write PMS API implementation Guide." This guide serves as an all-in-one resource for developers, implementers, and stakeholders working on the adoption and implementation of medical standards based on Fast Healthcare Interoperability Resources (FHIR). The package functions as a comprehensive toolkit that guarantees the efficient, accurate, and secure exchange of medical data fully compliant with the FHIR standard. Both documentation (PDF) and a ZIP file are provided for reference. This release is expected to significantly contribute to the standardization and improvement of interoperability in medical information systems related to pharmacovigilance within Europe.

Technology Note

FHIR(Fast Healthcare Interoperability Resources)は医療データ交換の国際標準。このエントリの関連技術: FHIR

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