EMA coordinates evaluation of medicinal products including radiopharmaceuticals across EU member states.
Centralized marketing authorization scientific advice and pharmacovigilance.
Works with national competent authorities for device and radiation matters.
Issues guidelines for clinical trials and quality of radiopharmaceuticals.
NRC licenses and regulates medical use of byproduct material including PET and SPECT radiopharmaceuticals and therapeutic isotopes.
Regulations cover nuclear medicine PET SPECT radiopharmacy safe handling and radiation protection for staff and patients.
Part 35 medical use of byproduct material sets licensing training recordkeeping and safety program requirements.
NRC works with state regulators and FDA on radiopharmaceutical approval and clinical use oversight.
TGA assesses device conformity, registers devices and enforces safety standards.
Conformity assessment, postmarket monitoring and recalls.
Participates in international regulatory harmonization and reliance frameworks.
Publishes device and radiation related guidance for manufacturers and clinicians.
MHRA oversees device conformity clinical investigations and postmarket vigilance for imaging modalities in the United Kingdom.
Guidance covers CT MRI ultrasound mammography and nuclear medicine device safety and clinical investigation requirements.
MHRA has established UK specific regulatory pathways and guidance following EU transition.
Manufacturers and clinical users follow MHRA guidance for device placement and safety in UK imaging services.
