Decristoforo Clemens, Penuelas Ivan, Patt Marianne, Todde Sergio
Department of Nuclear Medicine, Medical University of Innsbruck, Innsbruck, Austria -
Radiopharmacy Unit, Department of Nuclear Medicine, Clinical University of Navarra, Pamplona, Spain.
Q J Nucl Med Mol Imaging. 2017 Jun;61(2):135-144. doi: 10.23736/S1824-4785.17.02965-X. Epub 2017 Jan 26.
The development of novel radiopharmaceuticals is very rapid and highly innovative both for diagnostic and therapeutic applications. The translation into the clinic, however, is hampered by the high regulatory demands in Europe. This article describes the main rules, guidelines and guidance documents in the European Union in relation to the pharmaceutical regulatory framework. Until today a great number of radiopharmaceuticals are introduced clinically using specific national pathways outside the clinical trial regulation and examples are provided. In this context, the European Pharmacopoeia with a legal status plays an important role in defining quality standards. For clinical trials the application system and regulatory framework in Europe is currently considerably changing. Whereas the current clinical trial directive requires a lengthy and complicated national application process, the new regulation 536/2014 will introduce a streamlined and unified European application process. This new regulation also takes into account the specific properties of radioactive investigational medicinal products and has introduced exceptions for good manufacturing practices (GMP) and labelling for radiopharmaceuticals. Besides the main regulatory texts, several guidelines have been published, e.g. related to toxicity testing or first in man studies. In relation to radiopharmaceuticals professional organization, in particular the EANM, have published a number of documents in relation to GMP, documentation and toxicity studies, that support professionals in the application process. All these documents are summarized and discussed.
新型放射性药物的研发速度非常快，在诊断和治疗应用方面都具有高度创新性。然而，向临床转化受到欧洲严格监管要求的阻碍。本文介绍了欧盟与药品监管框架相关的主要规则、指南和指导文件。直到如今，大量放射性药物是通过临床试验监管之外的特定国家途径引入临床的，并给出了相关示例。在此背景下，具有法律地位的《欧洲药典》在界定质量标准方面发挥着重要作用。对于临床试验，欧洲目前的应用体系和监管框架正在发生重大变化。现行的临床试验指令要求进行冗长且复杂的国家申请程序，而新的第536/2014号法规将引入简化且统一的欧洲申请程序。这项新法规还考虑到了放射性研究用药品的特殊性质，并对放射性药物的药品生产质量管理规范（GMP）和标签规定引入了例外情况。除了主要的监管文本外，还发布了一些指南，例如与毒性测试或首次人体研究相关的指南。关于放射性药物专业组织，特别是欧洲核医学协会（EANM），已经发布了一些与GMP、文件编制和毒性研究相关的文件，这些文件在申请过程中为专业人员提供支持。所有这些文件都进行了总结和讨论。
