Regulation EU No 536/2014: What’s New and What’s Changed

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.

Here are six things you need to know:

To learn more about the transition between Directive 2001/20/EC to Regulation EU No 536/2014, visit the European Commission website here (link is external), and contact Pharm-Olam to learn specifically about how your investigational product clinical trial may be affected.