Advanced EU Clinical Trial Portal (CTIS) Regulatory Guide Part 5 – pharmaceutical drug regulatory affairs Advanced EU Clinical Trial Portal (CTIS) Regulatory Guide Part 5 – pharmaceutical drug regulatory affairs Introduction to Pharmaceutical Drug Regulatory Affairs in the EU Context As clinical trials are pivotal in pharmaceutical development, understanding the regulatory requirements surrounding them is crucial for sponsors, investigators, and regulatory affairs teams. This article focuses on the requirements of the European Union’s Clinical Trial Information System (CTIS) and its implications on pharmaceutical drug regulatory affairs. The EU Clinical Trial Regulation (EU No 536/2014) aims to ensure the safety and…