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 | |
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) |