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* Correspondence: ipenuelas@unav.es Radiopharmacy Unit, Department of Nuclear Medicine, Clínica Universidad de Navarra (UNAV), IdiSNA, Pamplona, Spain Full list of author information is available at the end of the article The development of radiopharmaceuticals with high specificity and high potential is increasing dramatically. This opens new doors in clinical research and changes clinical management resulting in an increased pressure to conduct controlled clinical trials. The nuclear medicine community is currently facing challenges during the transition phase of the clinical trial regulations. In the EU the legislation related to clinical trials will be ruled by Regulation 536/2014, the so-called “Clinical Trial Regulation”. There are substantial changes when we compare this new regulation with the old (albeit currently applicable) Directive 2001/20.

The new Regulation on clinical trials in relation to radiopharmaceuticals: when and how will it be implemented?