Which standardization framework guides pharmacovigilance data exchange and signal detection globally?

• A. ISO/IEC 27001
• B. ICH E2B(R2) pharmacovigilance data standards
• C. ISO 13485
• D. HL7 FHIR safety signals

Answer: (B)

Global pharmacovigilance relies on a unified data exchange framework that standardizes how adverse event reports are transmitted and analyzed across borders. The ICH E2B(R2) pharmacovigilance data standards provide the standardized data elements, message structure, and transmission rules for electronic adverse event reports between regulators and marketing authorization holders. This common format enables timely, consistent sharing of safety data worldwide and supports reliable signal detection and trend analysis.

The other options address different domains: ISO/IEC 27001 is about information security management systems, ISO 13485 covers quality management for medical devices, and HL7 FHIR is a broad interoperability framework for health data that can support exchange but is not the specific global standard governing pharmacovigilance data exchange and signal detection.