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Table 2 Guideline documents from regulatory bodies concerning radiopharmaceuticals

From: Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals

Guideline/text

Origin/organization

Topic

References

EMA/CHMP/SWP/686140/2018: Guidance on non-clinical requirements for radiopharmaceuticals

EMA

Non-clinical requirements for radiopharmaceuticals–draft document

Guideline on the non-clinical requirements for radiopharmaceuticals [Internet] (2018)

Directive 2013/59/Euratom: BSS for protection against the dangers arising from exposure to ionising radiation

Euratom

Radiation Protection

EUR-Lex-32013L0059-EN-EUR-Lex [Internet] (2022)

Guidance on medical exposure in medical and biomedical research

EURATOM

Risk categories for radiation exposure in diagnostics

European Commission, Directorate-General for Environment NS and Civil Protection (1999)

EMEA/CHMP/QWP/306970 Guideline on radiopharmaceuticals

EMA

Quality requirements for radiopharmaceuticals when aiming for marketing authorization

EMA (2018)

FDA guidance 2011: nonclinical evaluation of late radiation toxicity of therapeutic radiopharmaceuticals

FDA

Therapeutic Radiopharmaceuticals

Research C for DE and Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals [Internet]. U.S. Food and Drug Administration (2020)

FDA guidance document: microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations, guidance for industry

FDA

Diagnostic Radiopharmaceuticals

US FDA Guidance. Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations, Guidance for Industry (2022)

FDA/ICH Guidance Document: Oncology Therapeutic Radiopharmaceuticals: Non-Clinical Studies and Labeling Recommendations, Guidance for Industry

ICH (FDA/EMA)

Therapeutic Radiopharmaceuticals

US FDA Guidance (2022)