Radiopharmaceuticals are highly regulated because they are controlled both as regular medicinal products and as radioactive substances. They are fundamentally different from other medicinal products and these regulations are not always adequate for their production. This can pose a hurdle for their development and clinical use.
The last decade was characterized by great regulatory changes especially for the preparation of IMPs. Novel radiopharmaceuticals are to a great extent developed at universities and hospitals and are prepared on a small scale in a non-industrial setting which is due to their relatively short half shelf life. They typically require preparation on an extemporaneous basis for individual patients.
The evaluation of the technical performance of a diagnostic agent for imaging comprises the procedural aspect, the quality and readability of diagnostic images and the reproducibility of their reading.
The new EU Regulation 536/2014 reviewing the main characteristics and singularities for Clinical Trials with radiopharmaceuticals have been reinforced in 2016.
PNS provides Clinical trials management with radiopharmaceuticals and biotracers in strict compliance with GCP and includes:
Feasibility assessment (CiteLine etc..) in order to provide innovative and strategic solution ensuring successful clinical planning
Reporting of clinical studies on behalf of pharmaceutical and biotechnology industries.