The radiopharmaceutical industry and European Union regulations.

After a brief historical introduction to Council Directives relating to the manufacture of radiopharmaceuticals the work of the Association of Radiopharmaceuticals Producers - Europe (ARPE) is discussed. ARPE has played a significant role as an officially recognized interlocutor with the EEC, influencing decisions on the registration of radiopharmaceuticals and labelling; this role is reviewed and difficulties identified. The future of radiopharmaceuticals is then considered; it is emphasized that harmonization of national laws by the European Council would represent a first step to enabling radiopharmaceutical manufacturers to access the largest possible market for their products.