Clemens Decristoforo, Renata Mikolajczak, Clive Naidoo, Suzanne Lapi, Ferid Haddad, David Emmanuel Schmid, Lurdes Gano, Ulli Köster, Thierry Stora
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引用次数: 0
Abstract
Background
Radionuclides are the essential component of radiopharmaceuticals, their production needs to consider pharmaceutical regulations and guidelines, also for clinical research applications.
Main body
In this paper we reflect on the pharmaceutical regulatory landscape for radionuclide production in Europe, with a focus on Good Manufacturing Practices (GMP). The challenges for novel production pathways and the pathways for non-GMP production of radionuclides are discussed.
Conclusion
In particular when radionuclides are used as starting materials, exemptions from GMP requirements are essential for clinical innovation and a common understanding is needed to enable the safe use of novel radionuclides for medical applications without unnecessary regulatory hurdles for the user.
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