TRS 1044 - Annex 3: IAEA/WHO guideline on good manufacturing practices for investigational

Overview

In view of the rapidly expanding field of molecular imaging and targeted radiopharmaceutical therapy, combined with the absence of dedicated guidance specific to the manufacture of investigational radiopharmaceuticals used in both early and late clinical trials, the World Health Organization (WHO), in partnership with the International Atomic Energy Agency (IAEA), has raised the urgency for the generation of a new IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical products.