On 5 October 2023, the European Medicines Agency (EMA) adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The CTIS plays a...more
Yesterday, the European Commission published two legislative proposals concerning the regulation of medicinal products in the European Union. The proposals seek to consolidate existing legislation into two instruments, a...more
Following the entry into application of the Clinical Trials Regulation (EU) 536/2014 (CTR) for all initial clinical trial applications on 31 January 2023, the European Medicines Agency (EMA) has published a Q&A document...more