Labelling and “CTR” – Is There a Clear Understanding Throughout the EU?

Posted on 11/3/21

End of January 2022, the new EU Regulation 536/2014 on Clinical Trials (“CTR”) will finally come into force. Especially for the labelling requirements of clinical trial supplies, we are expecting a true harmonization throughout the EU. When reading the guideline, one can feel that they are not as clear as expected, especially some wording around Non-IMP´s, which are now called AMPs (“Auxillary Medicinal Products”) and the labelling requirements of authorized (marketed) AMPs and IMPs leads to confusion.

When talking to different experts in that area, the opinions differ on whether there is a requirement of labelling locally marketed drugs that are used in EU clinical trials. In addition, those different opinions might lead again to different interpretations of the guideline by local authorities. If that is the case, does the new guideline really lead to harmonization and a clear understanding of labelling requirements throughout the EU?

Myonex is in contact and exchanges information constantly with different experts in that area as well as gathering opinions of local authorities in various EU markets. Monitoring the regulatory landscape closely and understanding the requirements is key to successful trials in the future.

Written by Sandra Schomburg, Associate Director, Business Development