Position statement on radiopharmaceutical production for clinical trials

G. Bormans; A. Buck; A. Chiti; M. Cooper; J. Croasdale; M. Desruet; V. Kumar; Y. Liu; I. Penuelas; C. Rossetti; R. Schiavo; S. W. Schwarz; A. D. Windhorst

doi:https://doi.org/10.1186/s41181-017-0031-y

Position statement on radiopharmaceutical production for clinical trials

G. Bormans, A. Buck, A. Chiti, M. Cooper, J. Croasdale, M. Desruet, V. Kumar, Y. Liu, I. Penuelas, C. Rossetti, R. Schiavo, S. W. Schwarz, A. D. Windhorst

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	12
Number of pages	1
Journal	EJNMMI radiopharmacy and chemistry
Volume	2
Issue number	1
DOIs	https://doi.org/10.1186/s41181-017-0031-y
Publication status	Published - 29 Dec 2017

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https://doi.org/10.1186/s41181-017-0031-y

Cite this

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title = "Position statement on radiopharmaceutical production for clinical trials",

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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TY - JOUR

T1 - Position statement on radiopharmaceutical production for clinical trials

AU - Bormans, G.

AU - Buck, A.

AU - Chiti, A.

AU - Cooper, M.

AU - Croasdale, J.

AU - Desruet, M.

AU - Kumar, V.

AU - Liu, Y.

AU - Penuelas, I.

AU - Rossetti, C.

AU - Schiavo, R.

AU - Schwarz, S. W.

AU - Windhorst, A. D.

PY - 2017/12/29

Y1 - 2017/12/29

N2 - 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.

AB - 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.

U2 - https://doi.org/10.1186/s41181-017-0031-y

DO - https://doi.org/10.1186/s41181-017-0031-y

M3 - Article

SN - 2365-421X

VL - 2

SP - 12

JO - EJNMMI radiopharmacy and chemistry

JF - EJNMMI radiopharmacy and chemistry

IS - 1

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