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European Journal of Nuclear Medicine and Molecular Imaging

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01-11-2014 | Editorial

Radiopharmaceuticals are special, but is this recognized? The possible impact of the new Clinical Trials Regulation on the preparation of radiopharmaceuticals

Authors: C. Decristoforo, I. Penuelas, P. Elsinga, J. Ballinger, A. D. Winhorst, A. Verbruggen, F. Verzijlbergen, A. Chiti

Published in: European Journal of Nuclear Medicine and Molecular Imaging | Issue 11/2014

Excerpt

Dear Sir, …

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The European Parliament and the Council of the European Union. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Union 2001;L(121):34–44.

Decristoforo C, Peñuelas I. Towards a harmonized radiopharmaceutical regulatory framework in Europe? Q J Nucl Med Mol Imaging 2009;53(4):394–401.PubMed

European Commission. EudraLex, Volume 4. Good manufacturing practice (GMP) guidelines. Annex 13: Investigational Medicinal Products. 2010. http://ec.europa.eu/health/files/eudralex/vol-4/2009_06_annex13.pdf. Accessed 1 June 2014.

Mather SJ, Maltby P, Ellis B, O’Docherty M, Lewington V, Nunan T, et al. The qualified person in radiopharmacy. Nucl Med Commun 2010;31(3):187–9.PubMedCrossRef

Decristoforo C, Elsinga P, Faivre-Chauvet A, Farstad B, Meyer G, Mikolajczak R, et al. The specific case of radiopharmaceuticals and GMP–activities of the Radiopharmacy Committee. Eur J Nucl Med Mol Imaging 2008;35(7):1400–1.PubMedCrossRef

Elsinga P, Todde S, Penuelas I, Meyer G, Farstad B, Faivre-Chauvet A, et al. Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. Eur J Nucl Med Mol Imaging 2010;37(5):1049–62.PubMedCrossRefPubMedCentral

Verbruggen A, Coenen HH, Deverre JR, Guilloteau D, Langstrom B, Salvadori PA, et al. Guideline to regulations for radiopharmaceuticals in early phase clinical trials in the EU. Eur J Nucl Med Mol Imaging 2008;35(11):2144–51.PubMedCrossRef

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European Parliament and Council of the European Union. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Off J Eur Union 2014;L(158):1–76. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2014_158_R_0001&from=ES. Accessed 1 June 2014.

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Pharmaceutical Inspection Co-operation Scheme. Document PE 010–4, Annex 3: Good practices for the preparation of radiopharmaceuticals in healthcare establishments. 2014. http://www.picscheme.org/bo/commun/upload/document/pe-010-4-guide-to-good-practices-for-the-preparation-of-medicinal-products-in-healthcare-establishments-1.pdf. Accessed 1 June 2014.

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EDQM. 5.19. Extemporaneous preparation of radiopharmaceutical preparations. Pharmeuropa [Internet] 2014;26(2):1–10. http://pharmeuropa.edqm.eu/TextsForComment/NetisUtils/srvrutil_getdoc.aspx/0L3atCJKrELmrCJamC4KkQ7Hj//51900E.pdf. Accessed 1 June 2014.

Title: Radiopharmaceuticals are special, but is this recognized? The possible impact of the new Clinical Trials Regulation on the preparation of radiopharmaceuticals
Authors: C. Decristoforo
I. Penuelas
P. Elsinga
J. Ballinger
A. D. Winhorst
A. Verbruggen
F. Verzijlbergen
A. Chiti
Publication date: 01-11-2014
Publisher: Springer Berlin Heidelberg
Published in: European Journal of Nuclear Medicine and Molecular Imaging / Issue 11/2014
Print ISSN: 1619-7070
Electronic ISSN: 1619-7089
DOI: https://doi.org/10.1007/s00259-014-2838-z

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Radiopharmaceuticals are special, but is this recognized? The possible impact of the new Clinical Trials Regulation on the preparation of radiopharmaceuticals

Excerpt

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