Regulatory Decision Summary for GalliaPharm

The market authorization was based on review of the chemistry and manufacturing data for the GalliaPharm generator. The process was validated by manufacturing six batches (four from Cyclotron Co., Ltd [CYC] and two from Department of Energy [DOE]). The activity of the six generators covered the activity range of 0.74-1.85 gigabecquerel (GBq) at calibration. All acceptance criteria for the in-process controls and release testing were met. Data from the six generators manufactured at Eckert & Ziegler Radiopharma GmbH demonstrate that the process is capable of consistently manufacturing generators that meet pre-established specifications, indicating a robust process. The control strategies for the germanium (⁶⁸Ge) chloride solution (parent nuclide solution of the active substance) and the GalliaPharm generator were all reviewed and validated. Each of these met the relevant acceptance criteria for in process controls and release testing. Batch analysis data were reviewed, and demonstrated consistency and reproducibility with respect to the established manufacturing processes and controls.

The gallium (⁶⁸Ga) chloride eluted from the GalliaPharm generator met specifications for sterility and bacterial endotoxin levels defined in a European Pharmacopeia monograph.

The GalliaPharm generator has no clinical indication and its eluate, Gallium (⁶⁸Ga) Chloride solution, is not intended for direct administered to patients. The eluate, Gallium (⁶⁸Ga) chloride solution, is used exclusively for in vitro radiolabelling of specific carrier molecules, which have been developed and authorised for radiolabelling with this radionuclide, to produce the final radiopharmaceutical product for use in diagnostic imaging with positron emission tomography (PET).