Towards a harmonized radiopharmaceutical regulatory framework in Europe?

Despite European unification regarding a common legal framework for many aspects of pharmaceutical production including industrial manufacture of pharmaceuticals, the practice of pharmacy in general, and of radiopharmacy in particular, differs substantially and are mainly regulated at the national level. Herein the authors discuss major European documents relevant for radiopharmacy practice in Europe and recent developments on the national level especially regarding the small-scale preparation of radiopharmaceuticals (RP). Issues related to marketing authorization (and exemptions from it), standards of preparation, quality requirements, regulations of clinical trials and education will be outlined. Standards for the industrial preparation of pharmaceuticals are defined in "Good Manufacturing Practice" (GMP), not taking into account specific requirements for the small scale, extemporaneous preparation of RP. The European Association of Nuclear Medicine EANM has published several documents based on GMP and called "Good Radiopharmaceutical Practice" (cGRPP) to specifically address this in an attempt to harmonize RP preparation across Europe. Clinical trials have been hampered by the introduction of directive 2001/20/EC again aimed at the marketing track of industrial production and currently a number of activities are ongoing to counterbalance this problem in radiopharmaceutical research. Additionally, the role of the European Pharmacopoeia in regulating quality requirements and the need for specific education and training in the small scale radiopharmaceutical preparation are also discussed.