Aspetti regolatori dei radiofarmaci

Legislative decree 219/06 defines radiopharmaceuticals as \uabany medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose\ubb. Nowadays it is possible to make a distinction, regulatory wise, between radiopharmaceuticals compounded in hospitals and radiopharmaceuticals produced in industries. Many open and controversial issues must be faced to allow compliance with the current European and national legislation. Among them it is important to underline the high number of radiopharmaceuticals on the market from before 1992, did not yet receive the Marketing Authorization (MA); the production of some radiopharmaceuticals in hospitals with cyclotron, like for example 18-FDG, as officinal formula; the difficulties of the nuclear medicines centres in fulfilling the national Good Compounding Practice of radiopharmaceuticals preparations; a still confused scenario for experimental radiopharmaceuticals