指令
立法
授权
业务
销售授权
放射性核素
放射性核素治疗
欧洲共同体
欧洲联盟
风险分析(工程)
医学
核医学
政治学
计算机科学
法学
国际贸易
生物信息学
计算机安全
物理
生物
程序设计语言
量子力学
作者
Oliver Neels,Marianne Patt,Clemens Decristoforo
标识
DOI:10.1186/s41181-019-0074-3
摘要
The EU directive 2001/83 describes the community code for medicinal products for human use including radiopharmaceuticals. In its current definition, also radionuclide precursors, such as fluorine-18, need to hold a marketing authorization before being placed on the market. The potential of novel radiopharmaceuticals for nuclear medicine is, although encouraged by European legislation and its respective guidance documents, therefore hampered by the regulatory framework. An update of EU directive 2001/83 would be beneficial for the development of novel radiopharmaceuticals and a safe advance in nuclear medicine.
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