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The radiopharmaceutical industry and European Union regulations.

作者信息

Fallais C J, Sivewright S, Ogle J R

机构信息

Association of Radiopharmaceuticals Producers - Europe, Rue de la Pepiniere 1/2, B-1000 Brussels, Belgium.

出版信息

Eur J Nucl Med. 1997 Jan;24(1):77-9. doi: 10.1007/BF01728314.

DOI:10.1007/BF01728314
PMID:9044882
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.

摘要

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