European rules to bring novel radiopharmaceuticals to the clinic.

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European rules to bring novel radiopharmaceuticals to the clinic.

Q J Nucl Med Mol Imaging. 2017 Jan 26;:

Authors: Decristoforo C, Penuelas I, Patt M, Todde S

Abstract
The development of novel radiopharmaceutical 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 GMP and labelling for radiopharmaceuticals. Besides the main regulatory texts a number of guidelines have been published, e.g. related to toxicity testing or first in man studies. In relation to radiopharmaceuticals professional organisation, 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.

PMID: 28124548 [PubMed - as supplied by publisher]

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