EANM Position on the In-House Preparation of Radiopharmaceuticals

The daily clinical practice in Nuclear Medicine makes use of radiopharmaceuticals that either are obtained from
external commercial suppliers or prepared in-house for immediate use. The latter are usually non-commercial
preparations that represent the major source of radiopharmaceuticals for essential routine Nuclear Medicine
practices for both diagnostic and therapeutic applications. According to European legislation, namely directive
2001/83/EC, radiopharmaceuticals that are commercially distributed must have a marketing authorization (MA)
to be placed on the market. The availability of this type of finished radiopharmaceutical products with MA ready
to use is limited due to different reasons: one is the very short half-life or shelf life, which limits the shipment of
these radiopharmaceuticals from external sources. In addition, the market potential for radiopharmaceuticals that
are used in rare clinical indications is limited to be financially attractive for pharmaceutical industry, and therefore
the number of MA applications for radiopharmaceuticals is concise.
However, the development of innovative radiopharmaceuticals usually takes place in radiopharmacies, research
centres or nuclear medicine laboratories. Practically all recent major clinical breakthroughs in Nuclear Medicine
over the last decade, exemplified by the success of theranostics with Somatostatin analogs and prostate cancer
applications, were based on the use of in-house preparations of these innovative products. In case a new
radiopharmaceutical has both the technical (half-life) and clinical potential to be produced and distributed
commercially, these new radiopharmaceuticals more frequently make their way to pharmaceutical companies that
take over from academia and provide funding for further clinical trials besides phase 0 / phase I.
European legislation treats radiopharmaceuticals used in the preparation process of a radiopharmaceutical different
than other, i.e., non-radioactive pharmaceuticals, by requiring a marketing authorization not only for ready to use
radiopharmaceuticals that are to be placed on the market but as well for starting materials such as radionuclide
generators, radionuclide precursors and kits. To avoid misunderstanding, we shall refer throughout the remainder
of this document to the term “licensed” for starting materials with a MA.
This document describes the EANM commitment and support to the non-commercial in-house preparation of
radiopharmaceuticals for direct use in compliance with European and national regulations, including the
“compounding” using licensed starting materials (with MA) such as kits, radionuclide generators or radionuclide
precursors, as well as the preparation of diagnostic (PET and SPECT) and therapeutic radiopharmaceuticals using
more complex methods and usually unlicensed starting materials (without MA). Starting point for
recommendations have been laid down in the guidelines as described in the current Good Radiopharmaceutical
Practice (cGRPP).