Radiopharmaceutical preparations: what are the legislative differences across Europe?
نویسندگان
چکیده
Abstract Objectives Radiopharmaceuticals, since the discovery of first medical application radioactive isotope, have been essential therapeutics for diagnosis and treatment numerous diseases. Since Directive 2001/83/EC entered in force, European regulatory authorities established a harmonised framework to set quality requirements industrial production radiopharmaceuticals. However, little is known about harmonisation extemporaneous preparation radiopharmaceutical preparations (EPRPs) among countries. In this context, study aims provide an overview national on EPRPs five countries (i.e. UK, Spain, France, Germany Italy). Methods Five different frameworks were compared based results literature search electronic databases PubMed, Google scholar). Key findings Unlike industrially produced radiopharmaceuticals, highlighted that still not fully at level many provisions are regulated by local laws. Similarities differences exist countries, both regarding standards educational courses operators involved attend. Conclusions The affecting access therapies citizens who equally guaranteed when has be prepared meet their needs.
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ژورنال
عنوان ژورنال: Journal of Pharmaceutical Health Services Research
سال: 2021
ISSN: ['1759-8885', '1759-8893']
DOI: https://doi.org/10.1093/jphsr/rmab033