EMA Extends PV Inspections to Cover Subcontractors

EMA and the Heads of Medicines Agencies (HMA) have published a revised guideline on pharmacovigilance inspections that closes a gap marketing authorisation holders have used to shield subcontractors from direct regulatory scrutiny. Revision 2 of Good Pharmacovigilance Practices (GVP) Module III, published 4 September 2026, confirms that competent authorities can inspect a subcontractor performing pharmacovigilance tasks even when the subcontract itself contains no clause requiring the subcontractor to submit to inspection.

Why the subcontract language stopped being enough

Marketing authorisation holders routinely subcontract parts of their pharmacovigilance system — case processing, literature screening, signal detection — to specialised service providers. Until now, GVP Module III's inspection reach depended in practice on what the subcontract itself said about accepting inspection. The revised guideline removes that dependency: a competent authority's ability to inspect a subcontractor no longer turns on whether the contract between the marketing authorisation holder and the subcontractor happened to include an inspection clause.

The update responds directly to Commission Implementing Regulation (EU) 2025/1466, adopted 22 July 2025, which amended the pharmacovigilance rules first set out in 2012. That regulation tightened what a subcontracting arrangement must cover — roles, responsibilities, data sharing, audit rights, and inspection access — and barred a subcontractor from further subcontracting pharmacovigilance tasks without the marketing authorisation holder's written consent. Most of its provisions apply from 12 February 2026; the GVP Module III revision brings the inspection guidance into line with that framework.

Remote inspections get a formal standard

The revision separately updates guidance on remote inspections, a practice that expanded out of necessity in recent years and has since become routine. Under the revised text, the inspectorate decides case-by-case whether a remote inspection can deliver an adequate overview of how a pharmacovigilance system functions, rather than treating an on-site visit as the default and remote review as an exception requiring special justification. That gives inspectorates more flexibility in scheduling and scope, at the cost of removing a presumption sponsors could previously rely on.

What marketing authorisation holders should do

The practical effect lands on pharmacovigilance system master files and subcontracting agreements. A marketing authorisation holder's exposure during an inspection now runs through every subcontractor performing pharmacovigilance activities, regardless of what the underlying contract says about inspection rights — which means the master file needs to accurately map every subcontracted activity, and audit programmes need to reach subcontractors with the same rigor as in-house functions. The guideline was reviewed by EMA's Pharmacovigilance Inspectors' Working Group on 2 June 2026, agreed by PRAC on 6 July 2026, and agreed by the Co-ordination Group for Mutual Recognition and Decentralised Procedures before its 4 September publication.