Advertisement

The specific case of radiopharmaceuticals and GMP—activities of the Radiopharmacy Committee

  • C. DecristoforoEmail author
  • P. Elsinga
  • A. Faivre-Chauvet
  • B. Farstad
  • G. Meyer
  • R. Mikolajczak
  • I. Penuelas
  • P. Unak
  • G. Westera
  • The Radiopharmacy Committee of the EANM
Letter to the Editor

Dear Sir,

We have read with great interest the Editorial by Långström and Hartvig [1] discussing the increasing demands from current Good Manufacturing Practice (cGMP) regulations for radiopharmaceutical preparations. We agree with the authors that regulatory issues have had a dramatic impact on the development of radiopharmaceutical preparation and also on the Nuclear Medicine Community in general over the last years. Notwithstanding the importance of GMP regulations to ensure adequate safety, quality and potency of medicinal products, it also has to be considered that the application of current GMP regulations to the non-commercial production of radiopharmaceuticals, mainly for in-house use, is imposing excessive hurdles on the everyday work of thousands of nuclear medicine practitioners across Europe. Furthermore, the application of a legislation framework designed for the industrial production and marketing of non-radioactive medicinal products to the whole radiopharmaceutical...

Keywords

Post Graduate Education Current Good Manufacture Practice Current Good Manufacture Post Graduate Programme Tracer Concentration Level 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. 1.
    Långström B, Hartvig P. GMP—three letters with many interpretations: protection of patients or killing the clinical and research applications of PET. Eur J Nucl Med Mol Imaging 2008;35:693–4.PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • C. Decristoforo
    • 1
    Email author
  • P. Elsinga
    • 2
  • A. Faivre-Chauvet
    • 3
  • B. Farstad
    • 4
  • G. Meyer
    • 5
  • R. Mikolajczak
    • 6
  • I. Penuelas
    • 7
  • P. Unak
    • 8
  • G. Westera
    • 9
  • The Radiopharmacy Committee of the EANM
  1. 1.Clinical Department of Nuclear MedicineMedical University InnsbruckInnsbruckAustria
  2. 2.PET-centerGroningen University HospitalGroningenThe Netherlands
  3. 3.Département de Recherche en CancérologieUniversité de Nantes, INSERMNantesFrance
  4. 4.Isotope LaboratoriesInstitute for Energy TechnologyKjellerNorway
  5. 5.Medizinische Hochschule Hannover, Klinik f. NuklearmedizinHanoverGermany
  6. 6.Radioisotope Centre POLATOM, Research and DevelopmentOtwockPoland
  7. 7.Nuclear Medicine;CIMA-CUN, MicroPET Research Unit, Clínica UniversitariaUniversity of NavarraPamplonaSpain
  8. 8.Department of Nuclear Applications, Institute of Nuclear SciencesEge UniversityBornovaTurkey
  9. 9.Nuclear MedicineUniversity Hospital ZurichZurichSwitzerland

Personalised recommendations