PEI RADIOPHARMACEUTICALS IN EUROPE - CURRENT USE AND DATA RELEVANT FOR THE FORMULATION OF SUMMARIES OF PRODUCT CHARACTERISTICS (SPCS)

The increasing use of radiopharmaceuticals for positron emission tomog raphy (PET) has come to the attention of regulatory bodies. In order t o help authorities in all aspects, the EANM has formed a task group fo r licensing PET radiopharmaceuticals; this group has surveyed the use of these compounds in Europe by a questionnaire. The number of PET cen tres that responded to the questionnaire was 26, which included more t han 90% of the larger European PET centres. The survey showed that 2-[ F-18]fluoro-2-deoxyglucose is by far the most important PET radiopharm aceutical with more than 200 applications per week, followed by [O-15] water, [O-15]carbonmonoxide, [N-13]ammonia, [(11C)]-L-methionine, and L-6-[F-18]fluoro-DOPA. More than 25 other PET radiopharmaceuticals are in regular use, however, at rather low application frequencies, The d ata were used by the European Pharmacopoeia Commission for its priorit y rating for requesting the formulation of monographs, Since it is lik ely that group registrations will be is sued by authorities for the PE T radiopharmaceuticals, relevant data on toxicity and dosimetry for th e formulation of summaries of product characteristics have been collec ted by the task group as well.