Is Your Clinical Supply Strategy Ready For EU CTR?

In May 2014, the European Union Clinical Trial Regulation (EU CTR) No. 536/2014 was passed, replacing the EU directive No. 2001/20/EC, to enhance clinical trial safety, efficiency, transparency, and collaboration. At the end of January 2022, the regulation finally went into effect, leaving life sciences companies three years to transition and meet the new requirements.

One of the most significant changes in the new regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). The regulation also places increased emphasis on the main contact of the trial, if there’s an implementation grace period and what will/can be the role of Interactive Voice/Web Response Systems (IxRS). So, what are the implications of these changes and how will they affect outer immediate packaging?