On 23 July 2025, the Official Journal of the European Union published a European Commission Implementing Regulation of 22 July 2025 which provides for tailored updates to the rules on the performance of pharmacovigilance activities for medicinal products (Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025 “amending Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council”; the Regulation – see, attachment).

The updates introduced by the Regulation take account of (i) practical experience in applying the initial pharmacovigilance rules; (ii) technical and scientific progress; and (iii) international harmonisation in pharmacovigilance.

Key novelties are:

• To reduce the administrative burden for marketing authorisation holders (MAHs) and competent authorities, only “major or critical” deviations from pharmacovigilance procedures must now be documented in the pharmacovigilance system master file until resolved, replacing the requirement to document any deviations (see, amended Article 4(3));
• The Regulation prescribes the content of the contract between MAHs and third parties to whom specific pharmacovigilance activities are subcontracted (and of further subcontracts entered into by that third party) to ensure that (i) each party’s roles and responsibilities are clearly defined; and (ii) third parties agree to be audited by or on behalf of MAHs and inspected by competent authorities (although such audits and inspections can take place irrespective of whether this is mentioned in the subcontract) (see, new Article 6(3) and (4) and Article 13(1a));
• The rules on MAH audits of their quality system are strengthened with the confirmation that such audits should “individually or taken together, cover all pharmacovigilance activities for a defined period” (see, amended Article 13(1));
• In view of “experience acquired from […] monitoring of the data in the Eudravigilance database” by MAHs, the Regulation (i) clarifies that MAHs are required to both monitor and use the data available in the Eudravigilance database together with data from other available sources, but that they should monitor only signals related to a suspected adverse reaction; and (ii) updates the requirements for signal validation and subsequent notification to the European Medicines Agency (EMA) and national competent authorities (see, amended Article 18(2) and (3), Article 19(1) and Article 21(3) and (4));
• References to internationally agreed terminology and formats and standards have been updated to reflect developments, facilitate information exchange and increase interoperability (see, amended Article 25(1) and (2) and Article 26(2));
• The mandatory content of the periodic safety update report is extended to include updates on the implementation of risk minimisation measures (see, amended Article 34(3)); and
• It is clarified that MAHs should put post-authorisation safety studies in the electronic post-authorisation study register maintained by EMA (see, new Article 36(5)).

The Regulation will apply from 12 February 2026, except for a few provisions which will already apply on 12 August 2025 (including the requirement for MAHs to use the data available in the Eudravigilance database).