by In2Pharma | Apr 4, 2025 | News
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....
by In2Pharma | Apr 4, 2025 | News
Europe The new European Health Technology Assessment (HTA) regulation came into force in January. The main goals of this EU HTA regulation (EU HTAR) are: to improve and speed up the availability of innovative medicines and medical devices to patients across the EU; to...
by In2Pharma | Dec 27, 2024 | News
Europe An update to Delegated Regulation (EU) 2024/1701, which amends Regulation (EC) No 1234/2008, has been published and will come into effect on 1 January 2025. This regulation addresses the examination of variations to the terms of marketing authorisations for...
by In2Pharma | Dec 2, 2024 | News
Europe As part of Regulation (EU) 2022/123, an EU platform has been realised to prevent, monitor, and manage any medicine shortages across the EU of centrally authorised medicines. The European Shortages Monitoring Platform (ESMP) has the purpose to facilitate...
by In2Pharma | Aug 26, 2024 | News
Europe We would like to inform you of a significant new EU regulation—the Ecodesign for Sustainable Products Regulation (ESPR)—which came into force on July 18th, 2024, replacing the previous 2009 legislation. This regulation is designed to make products more...
