Key updates
PV outsourcing
Contracts must define roles, data exchange, audit/inspection rights, and prohibit onward subcontracting without written consent. Third parties must accept audits and may be inspected by regulators.
Audits
Risk-based audits must cover all PV activities, including subcontracted work.
EudraVigilance
MAHs must monitor EV alongside other sources; authorities must monitor EV continuously. Signals needing further analysis must be confirmed within 30 days.
Data & reports
Updated requirements for ICSR minimum elements, literature references (with DOI), PSURs (RMM implementation/effectiveness), and PASS registration in EMA’s PAS register.
PSMF
Focus only on major/critical deviations, their impact, and resolution.
What does this mean to you?
This amendment closes long-standing operational gaps: it codifies what many inspectors already expect on third-party control, tightens signal management timelines, and pushes convergence with IDMP and robust RMM effectiveness reporting. MAHs should update contracts, refresh audit plans, and adapt SOPs for EV monitoring and reporting.
Changes take effect from 12 February 2026, so preparations should begin now.
关于作者
Division Head Vigilance
Almudena leads pharmacovigilance strategy and operations at QbD Group as Division Head of Vigilance, helping pharma and biotech companies build robust drug safety systems.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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