Challenges in the Small-Scale Preparation of Radiopharmaceuticals - A European Perspective
Clemens DECRISTOFORO*, **
* Clinical Department of Nuclear Medicine, Medical University Innsbruck, Austria
** Radiopharmacy Committee of the European Association of Nuclear Medicine

Summary

Radiopharmaceuticals (RP) are a special group of drugs often requiring preparation in hospitals on a small scale. They have to be handled in a legal framework that is mainly suited for conventional drugs and manufacture by large drug manufacturers.
Especially with the advent of positron emission tomography (PET) using radionuclides with ultra-short half–life, a need for specific regulations has become obvious as current practice in Europe today is highly variable. The main challenges in this respect are preparation standards (Good Manufacturing Practice), quality requirements, regulations for marketing authorization, and training of personnel. A number of initiatives were started to inform European institutions of the specific case of RP. Specific guidelines for the small-scale, non-commercial extemporaneous preparation of RP have been published, and a specialized postgraduate training program on the European level was introduced to offer a unified system to obtain appropriate expertise in the field of small-scale RP preparation. For RP, both due to their short half-life and the often limited clinical indication, the market size is usually very limited. Specific exemptions for clinical trials
in addition to routine application of RP are needed to cover patients’ needs. A unified European approach for RP would be of great importance to guarantee high standards in the quality and safety of RP, especially for those prepared extemporaneously.

Key Words :
Radiopharmaceuticals, European regulations, PET, SPECT, small scale preparation