Expert comment: Updated EU pharmacovigilance regulation – What has changed?

On 12 February 2026, the updated EU pharmacovigilance regulation became fully implemented. This regulation contains several important changes aimed at improving efficiency, clarity and compliance within pharmacovigilance systems. Below is a summary of some of the key updates.

Key updates

1. Pharmacovigilance System Master File (PSMF)
Only significant deviations from established pharmacovigilance procedures, along with their impact and the actions taken to manage them, should be documented in the pharmacovigilance system master file until they are resolved. This approach is intended to reduce unnecessary administrative burden for both applicants and competent authorities.

2. Subcontracting of Pharmacovigilance Activities
When a marketing authorisation holder outsources pharmacovigilance activities to a third party — either directly or through further subcontracting — there must be clear documentation describing the delegation arrangements, the responsibilities of all involved parties, and the procedures for audits and inspections. Any third party performing these tasks must agree to be audited by, or on behalf of, the marketing authorisation holder and to be inspected by competent authorities to ensure full compliance with pharmacovigilance requirements.

A subcontracted third party carrying out any part of the pharmacovigilance system must be subject to audits by, or on behalf of, the marketing authorisation holder and may be inspected by authorities, regardless of whether these obligations are explicitly stated in the subcontract. Subcontractors must have a clear understanding of their obligations, which should be defined in the contract; however, deficiencies in the subcontract cannot prevent audits or inspections from taking place.

3. Monitoring of data in EudraVigilance and Signal management
The requirements for marketing authorisation holders have been further clarified. Marketing authorisation holders are required to monitor data available in EudraVigilance  and to use this information in conjunction with data from other available sources. For the purpose of monitoring EudraVigilance data, only signals related to suspected adverse reactions should be considered.

Overall impact

The updated EU pharmacovigilance regulation strengthens oversight while reducing unnecessary administrative complexity. By clarifying documentation requirements, reinforcing responsibilities for subcontracted activities, and specifying expectations for signal monitoring, the regulation supports a more efficient and robust pharmacovigilance system across the EU.