Guidance documents for clinical trials

Here is a list of regulatory guidances to help you understand the regulatory requirements for conducting clinical trials.

Good Clinical Practice

Good Clinical Practice

Adopted guidelines

ICH guidelines

We adopt the following ICH guidelines for clinical trials, where applicable:

  • E2A: Pharmacovigilance
  • E6(R2): Good Clinical Practice
  • 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: Carcinogenecity Studies
  • S2: Genotoxicity Studies
  • S3A-S3B: Toxicokinetics and Pharmacokinetics
  • S4: Toxicity Testing
  • S5: Reproductive Toxicology
  • S6(R1): Biotechnology Products
  • S7A-S7B: Pharmacology Studies
  • S8: Immunotoxicology Studies
  • S9: Nonclinical Evaluation for Anticancer Pharmaceuticals
  • S10: Photosafety Evaluation