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.
Fallais
C J
CJ
Association of Radiopharmaceuticals Producers - Europe, Rue de la Pepiniere 1/2, B-1000 Brussels, Belgium.
Sivewright
S
S
Ogle
J R
JR
D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D006801:Humans; D009683:Nuclear Medicine / Q000331:legislation & jurisprudence; D019275:Radiopharmaceuticals
D019275:Radiopharmaceuticals