Guidance documents for clinical trials

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

Conduct of clinical trials during COVID-19

Conduct of clinical trials during COVID-19

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
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