Europe
In December 2024, a draft version of an amendment to the European legislation for pharmacovigilance activities (Implementing Regulation EU No. 520/2012) has been published by the European Commission. Public feedback was collected until the 15th of January 2025.
Implementing Regulation (EU) No 520/2012 is a key piece of legislation in the European Union that aims to enhance the safety of medicines in the EU and establishes requirements for the monitoring of drugs after they have been authorized. It outlines responsibilities for various stakeholders, including the European Medicines Agency (EMA), national health authorities, and marketing authorization holders.
As for the anticipated amendments in 2025, these may involve updates to improve the efficacy and efficiency of pharmacovigilance processes, enhance data collection and sharing, and address emerging challenges such as the use of digital health technologies and real-world evidence. These amendments are likely to reflect ongoing developments in drug safety practices, regulatory science, and public health needs.
For the most accurate and detailed information, we will keep an eye on official announcements from the EMA and other regulatory bodies and will keep you informed.
More information about this initiative can be found here: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13195-Performance-of-pharmacovigilance-activities-for-human-medicines-update-of-Implementing-Regulation-EU-520-2012-_en