PET radiopharmaceuticals in Europe: current use and data relevant for the formulation of summaries of product characteristics (SPCs)

Abstract

The increasing use of radiopharmaceuticals for positron emission tomography (PET) has come to the attention of regulatory bodies. In order to help authorities in all aspects, the EANM has formed a task group for licensing PET radiopharmaceuticals; this group has surveyed the use of these compounds in Europe by a questionnaire. The number of PET centres that responded to the questionnaire was 26, which included more than 90% of the larger European PET centres. The survey showed that 2-[18f]fluoro-2-deoxyglucose is by far the most important pet radiopharmaceutical with more than 200 applications per week, followed by [15o]water, [15o]carbonmonoxide, [13n]ammonia, [11c]-l-methionine, and l-6-[18f]fluoro-dopa. More than 25 other PET radiopharmaceuticals are in regular use, however, at rather low application frequencies. The data were used by the European Pharmacopoeia Commission for its priority rating for requesting the formulation of monographs. Since it is likely that group registrations will be issued by authorities for the PET radiopharmaceuticals, relevant data on toxicity and dosimetry for the formulation of summaries of product characteristics have been collected by the task group as well.