Regulation of PET radiopharmaceuticals production in Europe

Abstract

Radiopharmaceuticals are a unique species of pharmaceuticals, containing both a drug and a radionuclide. This distinctive character can be challenging from a regulatory point of view as both pharmaceutical good manufacturing practice (GMP) and radiation safety aspects have to be balanced against each other. As a consequence of this, the production of PET radiopharmaceuticals must comply with both GMP and local radiation safety rules. This chapter describes some of the regulatory framework that covers the human use of PET radiopharmaceuticals in Europe. For preclinical applications there are no regulations on production, apart from the local/national animal rights rules. The different approaches which may be used to obtain permission to use the PET radiopharmaceutical in humans are described. For “first in human” use in a clinical trial, the content of the Investigational Medicinal Product Dossier is described, also an approach to minimise the very costly toxicological studies. The essentials of GMP and quality management systems are explained. The chapter ends with some future directions and convenient GMP approaches.