Key Updates To Implementing Regulation (EU) 520/2012

The evolving pharmaceutical landscape demands continuous regulatory adaptation to safeguard patient safety and ensure compliance. The European Commission’s proposed amendments to Implementing Regulation (EU) No 520/2012 represent a pivotal modernization of EU pharmacovigilance (PV) practices. These revisions represented a shift in pharmacovigilance processes, and had wide-reaching implications for marketing authorization holders (MAHs), national competent authorities (NCAs), and the European Medicines Agency (EMA).

Key changes made by Implementing Regulation (EU) No 520/2012 include removing the requirement for MAHs to monitor EudraVigilance (EV) for signal detection, shifting this responsibility solely to NCAs and EMA. Enhanced oversight of subcontracted PV activities is also proposed, requiring detailed documentation and auditability of third-party responsibilities. Updates to the Pharmacovigilance System Master File (PSMF) aim to reduce administrative burden by focusing only on significant procedural deviations. The amendments also introduce standardized data formats aligned with ISO IDMP and ICSR standards, clarify minimum reporting requirements for adverse reactions, and require comprehensive documentation in PSURs and public registration of all imposed non-interventional PASS. Implementation is expected in the second quarter of 2025, pending formal adoption.

These updates reinforce a more centralized, transparent, and technologically aligned EU pharmacovigilance system, ensuring efficient regulatory compliance and enhanced patient protection in a rapidly advancing healthcare environment.