by In2Pharma | Aug 14, 2025 | News
Europe The European Commission has published draft guidelines detailing the revised framework for variations to marketing authorisations of human medicines. These guidelines follow the updated Variation Regulation (EU) 2024/1701, which became applicable on 1 January...
by In2Pharma | Jul 3, 2025 | News
Europe As of October 17, 2023, the EU’s new microplastics restriction under the REACH regulation has officially entered into force (Commission Regulation (EU) 2023/2055). This restriction bans the sale of products containing intentionally added microplastics,...
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...
