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.
Mots-clés Pascal : Médecine nucléaire, Industrie pharmaceutique, Produit radioisotopique, Europe, Législation, Réglementation, Organisation
Mots-clés Pascal anglais : Nuclear medicine, Pharmaceutical industry, Radiopharmaceuticals, Europe, Legislation, Regulation, Organization
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0070280
Code Inist : 002B30A05. Création : 21/05/1997.