Quality data collection for clinical translation

Radiopharmaceuticals are considered Medicinal Products, thereby they must be prepared and applied within the regulated area of pharmaceuticals. This includes radionuclides, which have seen extraordinary advancements in research and development over the last decade regarding theranostics. Over the past four years WP4 of the PRISMAP project on Harmonisation and Standardisation has analysed the regulatory landscape in relation to chemical and pharmaceutical quality aspects of the use of novel radionuclides in radiopharmaceuticals, monitored the regulatory developments in this field and tried to communicate the challenges for clinical translation. Within these activities the revision of the pharmaceutical directive was reviewed and comments from PRISMAP provided. Contact with EMA resulted in dedicated events providing the radionuclides community point of view on GMP and other pharmaceutical regulations for novel radionuclides and input in IAEA activities were given. This is described in this deliverable. In the second part of this deliverable specific quality data and consideration for three major radionuclides from the PRISMAP portfolio, Tb-161, Cu-64 and Ac-225 are described. In particular, GMP requirements in the production and use of these radionuclides are addressed, and also specific quality issues and activities are described. This includes an outcome from an interlaboratory comparison study on Cu-64, comparison of quality data for Tb-161 provided within PRISMAP and specific developments on the quality of Ac-225. Overall, this deliverable provides a summary and insight into many aspects related to harmonisation and standardisation of the quality of novel radionuclides.