The Global Pharmacovigilance Framework · Section 2.12
~3 min read · The Drug Safety Coach — Global PV Career Course
Key points
Full text
The Global Pharmacovigilance Framework is not a static map of regulations — it is a dynamic, evolving ecosystem of shared accountability and collective intelligence, governed by international harmonisation standards (ICH), coordinated through the world’s largest safety database (WHO VigiBase), guided by ethical frameworks (CIOMS), operationalised through regional regulatory requirements, and increasingly powered by artificial intelligence.
For 2026, the framework has been materially updated in three important ways: EU Regulation 2025/1466 has reset operational expectations for all MAHs in the EEA; the CIOMS WG XIV final report has established the international standard for AI governance in PV; and the FDA-EMA joint AI principles have signalled transatlantic alignment on how AI in drug development — including safety surveillance — should be governed.
“The future of pharmacovigilance will not be defined by who holds the data, but by who can learn from it most responsibly.” — Vinay Kumar
Key references: Commission Implementing Regulation (EU) 2025/1466 (July 2025, applicable Feb 12, 2026) · CIOMS Working Group XIV Final Report (December 2025) · FDA-EMA Ten Guiding Principles of Good AI Practice (January 2026) · FDA Draft Guidance on AI for Regulatory Decision-Making (January 2025) · EU AI Act, Regulation (EU) 2024/1689 · EMA GVP Modules I-XVI (2025) · EMA GVP Module IX Rev 2: Signal Management (2025) · ICH E2A/E2B(R3)/E2C(R2)/E2E/E2F · CDSCO PV Guidelines (2024) · WHO-UMC VigiBase and VigiLyze documentation (2025) · DPDP Act, India (2023) · EMA DARWIN EU Network Operations Report (2025).
Quick check
Test yourself before moving on — no pressure, just click an answer.
1. Across this whole module, what single date should you remember as the deadline for full EU Regulation 2025/1466 compliance?