Radiopharmaceutical preparations: what are the legislative differences across Europe?

Abstract

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