Guidance documents for clinical trials

Innovation Office

• Submission of Innovation Office Requests [PDF, 401 KB] (updated 18 Oct 2024)

  • Appendix A: Innovation Office Request Form [DOC, 2.4 MB]

  • Appendix B: Suggested Format for the Briefing Document [DOC, 36 KB]

Clinical trial submissions

• Regulatory requirements for new application and subsequent submissions [PDF, 414 KB] (updated 28 Apr 2021)

New Clinical Trial Application

• Determination of whether a clinical trial requires a Clinical Trial Authorisation, Clinical Trial Notification or Clinical Trial Certificate [PDF, 448 KB] (updated 1 Mar 2021) 

• Multi-sponsor investigator-initiated trials [PDF, 243 KB] (updated 1 Mar 2021)

• Chemistry, Manufacturing and Controls Requirements for Cell, Tissue or Gene Therapy Products for Clinical Trials and Product Registration [PDF, 526 KB]

Clinical Research Materials

• Clinical Research Materials [PDF, 718 KB] (updated 1 Mar 2021) 

Subsequent Submissions

• Guidance on determining whether an amendment to a clinical trial is a substantial amendment [PDF, 332 KB] (updated 1 Mar 2021)

• Expedited safety reporting requirements for clinical trials [PDF, 493 KB] (updated 1 Mar 2021)

• Notification of serious breach [DOC, 280 KB] (updated 1 Mar 2021)

• Product defect reporting and recall procedures for therapeutic products and cell, tissue and gene therapy products [PDF, 588 KB]

Conducting clinical trials

Informed Consent

• Safeguards and consent requirements in vulnerable trial participants [PDF, 1.1 MB] (updated 2 Jan 2026)

• Consent requirements for clinical trials involving collection of human tissue [PDF, 217 KB] (updated 1 Oct 2021)

• Electronic consent [PDF, 381 KB] (updated 2 Jan 2026)

Investigational Product

• Labelling of investigational and auxiliary products in clinical trials [PDF, 597 KB] (updated 2 Jan 2026)

• Alternative approaches for investigational product management for clinical trials of locally registered products [PDF, 273 KB] (updated 2 Jan 2026)

• Investigational product repackaging at the investigator site [PDF, 322 KB] (updated 2 Jan 2026)

Good Clinical Practice

• Guidance on Good Clinical Practice compliance inspection framework [PDF, 415 KB] (updated 2 Jan 2026)

Conduct of clinical trials during a public health emergency

• Guidance on the conduct of clinical trials in relation to the COVID-19 situation [PDF, 197 KB] (updated 26 Aug 2022)

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(R3): Good Clinical Practice (GCP), Principles and Annex 1

• 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

• S12: Nonclinical Biodistribution Considerations for Gene Therapy Products

Other guidelines

• MOH Website: Guidance for Pharmacist Principal Investigator (1 Oct 2021)