We adopt the following ICH guidelines (https://www.ich.org/page/ich-guidelines) for clinical trials, where applicable:

• E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• E2F: Development Safety Update Report
• E6(R2): Good Clinical Practice (GCP)
• E7: Clinical Trials in Geriatric Population
• E8(R1): General Considerations for Clinical Trials
• E9(R1): Statistical Principles for Clinical Trials
• E10: Choice of Control Group in Clinical Trials
• E11(R1): Clinical Trials in Paediatric Population
• E14: Clinical Evaluation of QT
• E17: Multi-Regional Clinical Trials
• M3(R2): Nonclinical Safety Studies
• S1A: Guideline on the need for Carcinogenicity Studies of Pharmaceuticals
• S1B(R1): Testing for Carcinogenicity of Pharmaceuticals
• S1C(R2):Dose Selection for Carcinogenicity Studies of Pharmaceuticals
• S2: Genotoxicity Studies
• S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
• S3B: Guidance for Repeated Dose Tissue Distribution Studies
• S4: Toxicity Testing
• S5(R3): Reproductive Toxicology
• S6(R1): Biotechnological Products
• S7A: Safety Pharmacology Studies for Human Pharmaceuticals
• S7B: The Non-Clinical Evaluation of The Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
• S8: Immunotoxicology Studies
• S9: Nonclinical Evaluation for Anticancer Pharmaceuticals
• S10: Photosafety Evaluation
• S11: Nonclinical Paediatric Safety
• Q1A(R2): Stability Testing of New Drug Substances and Products
• ICH Topic Q 1 E Evaluation of Stability Data: NOTE for Guidance on Evaluation of Stability Data (CPMP/ICH/420/02)