The Use and Registration of PET-Radiopharmaceuticals

Abstract

The development of regulatory schemes, for the production of PET radiopharmaceuticals can be understood only, in view of the development of PET as a new diagnostic tool. It seems at the moment that PET starts to cross the border from a research tool to a ma! clinical utility. Although some extreme expectations of the expansion have not been fulfilled in the last two years, the steady increase in PET investments is a strong indicator for its success. However, the increasing availability in the USA, as well as in Japan and especially in Germany was not matched by regulatory actions, to back up the legal foundations for its clinical use. Reasons for the hampered development have been identified as being regulatory deficits, educational deficits, and struggles between interest groups, as well as the complexity of the method itself.

New ways of defining quality control demands and the qualification for responsibilities had to be developed within conservative bodies, as national drug licensing agencies, pharmacopoeial commissions, professional interest groups, and education departments.

Although regulatory approaches differ to quite some extent in many countries, harmonization efforts are observed not only in Europe, but also between Europe and the USA.

Nevertheless progress has been made in several of these fields during the last five years, especially within the field of production and quality control. It is hoped that in the coming two to three years many of the remaining issues can be solved.

A relatively unrestricted availability of fluorinated radiopharmaceuticals for PET will au- tomatically lead to an enormous demand. This can be derived from the high demand for double headed SPECT gamma cameras which can be operatea in coincidence mode. On the other hand this will further trigger an increase the of number of operational PET camera locations. In summary diagnostic PET procedures should become available as a clinical routine tool all over Europe, - at least in all locations close to universities and in larger cities -.