Following a public consultation period this summer, the European Medicines Agency (EMA) published revised transparency rules (s. here) for the EU Clinical Trials Information System (CTIS) on 6 October 2023. The CTIS serves as the single entry point for all clinical trials to be conducted in the EU/EEA under the Clinical Trials Regulation (EU) No. 536/2014 (CTR), comprising sponsor and authority workspaces and a publicly accessible database….
By: Allen & Overy LLP
By: Allen & Overy LLP
