BDO USA
Practical Considerations for EU Labeling Requirements of Investigational Drug Products
Pages
4
Time to read
10 mins
Publication
Language
English
Summary
This document provides essential insights into the EU labeling requirements for investigational drug products following the adoption of the Clinical Trials Regulation (CTR) No 536/2014. It highlights key differences between EU and US regulations, particularly regarding expiry labeling, and offers practical tips for compliance to ensure effective clinical supply chain management. Understanding these regulations is crucial for biopharmaceutical companies conducting clinical trials in Europe.
