Stepping into 2026, the challenge for marketing authorization holders (MAHs) is not only to address AI intrusion into pharmacovigilance but also to ensure their existing pharmacovigilance systems are compliant, all-through, controlled, data-driven, and inspection-ready for unannounced audits. For marketing authorization holders (MAHs) ensuring PV audit readiness, as always, stands as a key factor in 2026 too.
Why is PV audit so critical in 2026? Because major regulated regions like the EU, the US, and the UK continue to use a risk-based inspection approach for pharmacovigilance. Their core focus is on products and systems where the potential patient impact is higher.
What kind of Inspection and Audit Findings MAHs Can Expect?
As per the highlights of the recent EMA PhV Inspector’s Working Group report, the most frequent inspection findings in 2024 revolved around three common areas:
- Reporting of adverse reactions, delays, or errors in ICSR intake, medical review, and regulatory reporting
- Quality Management Systems (QMS)
- Management of the Pharmacovigilance system master file (PSMF), out-of-date/inaccurate PSMF content not reflecting the actual PV practice
- Poor vendor oversight
Consistently flagged issues:
- Signal management
- Risk management plans
- Literature monitoring
- Incomplete and poor documentation, and incomplete safety data exchange for CROs and other partners performing PV activities
- Misalignment with real-world practice (RWP)
- Missing audit trails
- Uncontrolled modifications
- Inadequately trained personnel in the compliance reviews
The Road Ahead for MAHs in PV Audits
Marketing Authorization Holders (MAHs) require a PV system that can withstand traceability and risk control. They should build a PV system that is robust and compatible with routine and unannounced audits from all perspectives. It should consolidate all global obligations into a single platform.
What is Needed from MAHs for Zero Findings in PV Audits?
- MAHs should strengthen their Quality Management Systems for Pharmacovigilance. Build and align their SoPs with real-time practice, implement appropriate deviation and CAPA management, and set and track KPIs, such as strictly adhering to ICSR timelines.
- Build robust workflows from case intake to submissions, and integrate validated databases.
- Update PSMF and RMPs ‘living’ documents whenever there is a change in process or product.
- Define clear signal detection strategies and reinforce risk management plans.
- Invest in training internal staff, vendor oversight, and mock inspections and audits for before-in-hand findings.
Overall, MAHs must perceive the PV audit-readiness not just as submitting humongous documentation and procedures, but as presenting a coherent, clear case that is self-sufficient and can be followed during inspections.
Have you evaluated its audit readiness? In a highly regulated landscape, checking and ensuring the quality of your processes is mandatory. Be it technical documentation, standard procedures, facility well-being, or simple SOPs, evaluate and identify gaps, and chalk out remediation plans for successful audits and easier market access. Consult a regulatory expert.