DOI: 10.1186/s41181-017-0031-yPages: 1-3

Position statement on radiopharmaceutical production for clinical trials

1. Radiopharmaceutical Research KU Leuven

2. University of Wurzburg

3. Humanitas University and Humanitas Research Hospital

4. Royal Liverpool University Hospital

5. Sandwell & West Birmingham Hospitals NHS Trust

6. Hospital Grenoble-Alpes

7. Sydney University, Sydney Medical School

8. European Organisation for Research and Treatment of Cancer (EORTC)

9. ClínicaUniversidad de Navarra

10. Ospedale Niguarda

11. Ospedale Belcolle

12. Washington University School of Medicine

13. VU University Medical Center

Correspondence to:
C. Rossetti
Email: claudio.rossetti@ospedaleniguarda.it

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Abstract

The EU regulation 536/2014 aims to facilitate the experimental use of diagnostic radiopharmaceuticals in particular for GMP requirements and needs to be applied in EU countries. As definitely clarified by this survey, the application is still far from being completed due to national restrictions that are conflicting with the content of the above EU regulation. Although the nuclear medicine centers are obliged to be compliant with national regulatory, national authorities have to be required to work towards full application of the regulation. On the other hand, an update of 536/2014 that includes therapeutic radiopharmaceuticals would also be beneficial to a rational and safe advance of nuclear medicine.

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  • Accepted: Sep 10, 2017
  • Online: Sep 29, 2017

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