by In2Pharma | Oct 13, 2025 | News
Europe Following the revision of the Variation Regulation effective as of 1 January 2025, the European Commission (EC) has adopted and published the final version of the guidelines concerning the classification of variations and the operation of the relevant...
by In2Pharma | Sep 18, 2025 | News
Europe The CMDh has published a new version of the cover letter template: CMDh/096/2009, Rev.8 (July 2025).With this update, the eCTD sequence number is no longer included. The use of the latest version is recommended for all new submissions going forward. The updated...
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....
