title: The radiopharmaceutical industry and European Union regulations.
abstract: 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.
authors.affiliation: Association of Radiopharmaceuticals Producers - Europe, Rue de la Pepiniere 1/2, B-1000 Brussels, Belgium.
authors.forename: C J
authors.initials: CJ
authors.lastname: Fallais
authors.forename: S
authors.initials: S
authors.lastname: Sivewright
authors.forename: J R
authors.initials: JR
authors.lastname: Ogle
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D006801:Humans; D009683:Nuclear Medicine / Q000331:legislation & jurisprudence; D019275:Radiopharmaceuticals
chemical_list: D019275:Radiopharmaceuticals