Abstract
BACKGROUND: Radionuclides are the essential component of radiopharmaceuticals, their production needs to consider pharmaceutical regulations and guidelines, also for clinical research applications. MAIN BODY: In this paper we reflect on the pharmaceutical regulatory landscape for radionuclide production in Europe, with a focus on Good Manufacturing Practices (GMP). The challenges for novel production pathways and the pathways for non-GMP production of radionuclides are discussed. CONCLUSION: In particular when radionuclides are used as starting materials, exemptions from GMP requirements are essential for clinical innovation and a common understanding is needed to enable the safe use of novel radionuclides for medical applications without unnecessary regulatory hurdles for the user.