title: European regulations for the introduction of novel radiopharmaceuticals in the clinical setting.
abstract: The development of novel radiopharmaceuticals is very rapid and highly innovative both for diagnostic and therapeutic applications. The translation into the clinic, however, is hampered by the high regulatory demands in Europe. This article describes the main rules, guidelines and guidance documents in the European Union in relation to the pharmaceutical regulatory framework. Until today a great number of radiopharmaceuticals are introduced clinically using specific national pathways outside the clinical trial regulation and examples are provided. In this context, the European Pharmacopoeia with a legal status plays an important role in defining quality standards. For clinical trials the application system and regulatory framework in Europe is currently considerably changing. Whereas the current clinical trial directive requires a lengthy and complicated national application process, the new regulation 536/2014 will introduce a streamlined and unified European application process. This new regulation also takes into account the specific properties of radioactive investigational medicinal products and has introduced exceptions for good manufacturing practices (GMP) and labelling for radiopharmaceuticals. Besides the main regulatory texts, several guidelines have been published, e.g. related to toxicity testing or first in man studies. In relation to radiopharmaceuticals professional organization, in particular the EANM, have published a number of documents in relation to GMP, documentation and toxicity studies, that support professionals in the application process. All these documents are summarized and discussed.
authors.affiliation: Department of Nuclear Medicine, Medical University of Innsbruck, Innsbruck, Austria - clemens.decristoforo@i-med.ac.at.
authors.forename: Clemens
authors.initials: C
authors.lastname: Decristoforo
authors.affiliation: Radiopharmacy Unit, Department of Nuclear Medicine, Clinical University of Navarra, Pamplona, Spain.
authors.forename: Ivan
authors.initials: I
authors.lastname: Penuelas
authors.affiliation: Clinic and Polyclinic for Nuclear Medicine, University of Leipzig, Leipzig, Germany.
authors.forename: Marianne
authors.initials: M
authors.lastname: Patt
authors.affiliation: Milano-Bicocca University, Monza, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Todde
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence; D055808:Drug Discovery; D005060:Europe; D005062:European Union; D006801:Humans; D019275:Radiopharmaceuticals
chemical_list: D019275:Radiopharmaceuticals