Position Paper to facilitate patient access to radiopharmaceuticals - considerations for a suitable pharmaceutical regulatory framework

Nuclear medicine has made enormous progress in the past decades. However, there are still significant inequalities in patient access among different countries, which could be mitigated by a suitable pharmaceutical regulatory framework and associated guidelines. This paper summarizes major considerations for a suitable pharmaceutical regulatory framework to facilitate patient access to radiopharmaceuticals. These include the distinct characteristics of radiopharmaceuticals advocating dedicated regulations, the impact of variable complexity of radiopharmaceutical preparation, personnel requirements, manufacturing practices and quality assurance, regulatory authorities interfaces, communication and training, as well as marketing authorization procedures to ensure availability of radiopharmaceuticals. Finally domestic and regional supply to ensure patient access via alternative regulatory pathways, including in-house production of radiopharmaceuticals, is described and an outlook on regulatory challenges faced by new developments, such as the use of alpha emitters, is provided. All these considerations are an outcome of a dedicated Technical Meeting organized by the IAEA in 2023.