Regulation EU No 536/2014: What’s New and What’s Changed
The European Medicines Agency (EMA)'s Clinical Trial Regulation (EU No. 536/2014), which governs research of medicinal products for human use, is scheduled to go into effect in October 2018. According to the EMA's official website, the Regulation "aims to create an environment that is favorable to conducting clinical trials in the European Union (EU), with the highest standards of safety for participants." The objective is to apply a set of rules consistently throughout the member states in the EU.