Decristoforo A, Peñuelas I
Clinical Department of Nuclear Medicine, Medical University Innsbruck, Innsbruck, Austria.
Q J Nucl Med Mol Imaging. 2009 Aug;53(4):394-401.
Despite European unification regarding a common legal framework for many aspects of pharmaceutical production including industrial manufacture of pharmaceuticals, the practice of pharmacy in general, and of radiopharmacy in particular, differs substantially and are mainly regulated at the national level. Herein the authors discuss major European documents relevant for radiopharmacy practice in Europe and recent developments on the national level especially regarding the small-scale preparation of radiopharmaceuticals (RP). Issues related to marketing authorization (and exemptions from it), standards of preparation, quality requirements, regulations of clinical trials and education will be outlined. Standards for the industrial preparation of pharmaceuticals are defined in "Good Manufacturing Practice" (GMP), not taking into account specific requirements for the small scale, extemporaneous preparation of RP. The European Association of Nuclear Medicine EANM has published several documents based on GMP and called "Good Radiopharmaceutical Practice" (cGRPP) to specifically address this in an attempt to harmonize RP preparation across Europe. Clinical trials have been hampered by the introduction of directive 2001/20/EC again aimed at the marketing track of industrial production and currently a number of activities are ongoing to counterbalance this problem in radiopharmaceutical research. Additionally, the role of the European Pharmacopoeia in regulating quality requirements and the need for specific education and training in the small scale radiopharmaceutical preparation are also discussed.
尽管欧洲在药品生产的许多方面（包括药品的工业制造）制定了统一的法律框架，但总体而言，药学实践，尤其是放射性药物药学实践，在很大程度上存在差异，且主要在国家层面进行监管。在此，作者讨论了与欧洲放射性药物药学实践相关的主要欧洲文件以及国家层面的最新发展，特别是关于放射性药物（RP）的小规模制备。将概述与上市许可（及其豁免）、制备标准、质量要求、临床试验法规和教育相关的问题。药品工业制备标准在《药品生产质量管理规范》（GMP）中定义，但未考虑RP小规模临时制备的具体要求。欧洲核医学协会（EANM）已基于GMP发布了几份文件，并称之为《放射性药物生产质量管理规范》（cGRPP），以专门解决这一问题，试图在全欧洲统一RP制备。2001/20/EC号指令的出台阻碍了临床试验，该指令同样针对工业生产的上市环节，目前正在开展一些活动以平衡放射性药物研究中的这一问题。此外，还讨论了欧洲药典在规范质量要求方面的作用以及小规模放射性药物制备中特定教育和培训的必要性。
