Pharmacovigilance (PV) Regulation (EU) 2025/1466 is not just an annotation to Regulation (EU) 520/2012. It is a key arrangement for MAHs to understand how seriously they should work on safety systems (design, contract, audit, and evidence – across all perspectives). The PV Regulation (EU) 2025/1466 brings some clarity to areas that had been treated as best practice rather than complex law. It also tightens expectations on PV compliance requirements for MAHs.
PV Regulation (EU) 2025 – What has been changed?
In simple terms, the PV Regulation (EU) 2025/1466 amendments revolve around four significant aspects, such as:
- how one can describe the PV system
- how one can subcontract the work
- how one can audit it
- how one can manage signals and studies
Key themes include:
- A more focused Pharmacovigilance System Master File (PSMF). It encourages documenting significant and critical deviations instead of every minor slip.
- Stronger rules for third‑party contracts and auditing. It enables regulators to notice exactly who does what in your PV ecosystem.
- Clearer expectations around signal management, EudraVigilance, and post‑authorisation studies. It includes new electronic registration and expanded PSUR content.
PV Regulation (EU) 2025/1466 – Changes to MAH Responsibilities
The PV Regulation (EU) 2025/1466 does not fully define the MAH’s responsibilities for Pharmacovigilance. It makes them harder to ignore. It makes MAH’s accountability to the entire PV system more visible. For MAHs, this translates into:
- Owning a single, coherent PV system description that will have enough operational insights that are auditable, including information about PV activities, key sites, QPPV oversight, and risk management
- Demonstrating that every outsourced activity, from case processing to signal analytics and PASS delivery, is governed by contracts that meet the new EU drug safety regulatory updates on roles, data flows, audits, and sub‑subcontracting.
- Being able to show how benefit–risk evaluation, PSUR strategy, RMP updates, and PASS decisions are driven by live safety data rather than by the calendar.
A PV Compliance Checklist for MAHs
To prepare for compliance, MAHs should consider covering/answering the following key aspects/queries in their Pharmacovigilance compliance checklist.
- PSMF and governance
- Does my PSMF capture only significant and critical deviations, with a clear trail of impact assessment and CAPA?
- Are all the PV sites and key functions (ICSRs, signals, PSURs, RMPs, PASS) I am responsible for mapped to owners and tools?
- Subcontracting and vendors
- Do all the PV contracts explicitly define responsibilities, safety data exchange methods, and audit and inspection arrangements? Do they have further limits on subcontracting, as required by the pharmacovigilance regulation (EU) 2025/1466?
- Is there a documented process for accepting/rejecting written consent especially when a vendor wants to subcontract parts of my PV tasks?
- Audits and quality system
- Has a risk‑based audit programme been defined that covers internal PV activities and all relevant vendors, with independent auditors and documented follow‑up?
- Are audit outcomes routinely integrated into QPPV system, closing the loop between findings and system change?
- Signal management & reporting
- Are my internal procedures aligned with the latest EU GVP changes 2025 for signal management, including updated roles in EudraVigilance monitoring, validation timelines, and documentation?
- Have templates and SOPs for PSURs, ICSRs, and literature monitoring been updated to reflect the tightened PV reporting requirements in the EU?
Having a comprehensive compliance checklist to follow and understanding the core responsibilities is the need of the hour for MAHs to be inspection-ready, where evidence matters the most. How can MAHs be inspection-ready? They should treat Pharmacovigilance as an integrated business system. With clear-cut control over contracts, data, and governance, the new compliance landscape is definitely manageable. If you are still dependent on legacy templates, the pressure might build up early on.
Going forward, the PV Regulation (EU) 2025/1466 isn’t the last regulatory update for drug safety. There will be many more and more. Be prepared and inspection-ready with an expert.