The EU regulation 536/2014 aims to facilitate the experimental use of diagnostic radiopharmaceuticals in particular for GMP requirements and needs to be applied in EU countries. As definitely clarified by this survey, the application is still far from being completed due to national restrictions that are conflicting with the content of the above EU regulation. Although the nuclear medicine centers are obliged to be compliant with national regulatory, national authorities have to be required to work towards full application of the regulation. On the other hand, an update of 536/2014 that includes therapeutic radiopharmaceuticals would also be beneficial to a rational and safe advance of nuclear medicine.

中文翻译：

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关于用于临床试验的放射性药物生产的立场声明。

欧盟法规536/2014旨在促进诊断性放射性药物的实验性使用，尤其是针对GMP要求，并且需要在欧盟国家中使用。正如本次调查明确阐明的那样，由于与上述欧盟法规的内容相抵触的国家限制，申请仍未完成。尽管核医学中心有义务遵守国家法规，但必须要求国家当局努力全面实施该法规。另一方面，包含治疗性放射性药物的536/2014更新也将有利于核医学的合理和安全发展。