PRISMAP, the European Medical Radionuclide Programme, brings together key nuclear research centres and leading clinical translational research facilities across Europe to provide a sustainable source of high purity grade new radionuclides for the starting research community. One of PRISMAP`s paramount aims is to standardise and harmonise research and development activities with novel radionuclides to cope with pharmaceutical regulatory requirements and provide guidance for clinical translation. The PRISMAP workshop: “Radionuclide Production to Nuclear Medicine Clinical Applications: Regulatory Standards and Harmonisation of Quality and Safety”, held in February 2022, brought together members of PRISMAP, professionals from industry, regulatory bodies, and overseas experts. It provided the basis for a dedicated document, which gives guidance for the early phase clinical research with novel radionuclides. It describes the current standards and provides a harmonised view of the European regulatory framework thereby complementing the existing regulatory framework without being legally binding.

The document includes terms and nomenclature for quality specifications of novel radionuclides within PRISMAP, followed by major aspects in production of radionuclides and the implementation of good manufacturing practices (GMP). The subsequent chapters cover quality specifications and quality control, with a designated chapter on metrology and medical physics aspects in clinical translation. The final chapter describes non-clinical safety and pharmacology aspects and provides an overview of the current regulatory guidance documents for preclinical testing.

This guidance document from the PRISMAP consortium serves as an essential and comprehensive source for radionuclide producers, radiopharmaceutical translational scientists, clinical and hospital based radiopharmaceutical development researchers through the complex jungle of pharmaceutical regulations and guidelines. It provides a harmonised view to standardise data required for clinical translation of novel radionuclides. The document can be found amongst our published reports.