Adopted guidelines
ICH guidelines
We adopt the following 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 - S1C: Carcinogenicity Studies
- S2: Genotoxicity Studies
- S3A - S3B: Toxicokinetics and Pharmacokinetics
- S4: Toxicity Testing
- S5(R3): Reproductive Toxicology
- S6(R1): Biotechnological Products
- S7A - S7B: Pharmacology Studies
- S8: Immunotoxicology Studies
- S9: Nonclinical Evaluation for Anticancer Pharmaceuticals
- S10: Photosafety Evaluation
- S11: Nonclinical Paediatric Safety