Innovation Office

• Submission on Innovation Office Requests (updated 18 Oct 2024)
  • Appendix A: Innovation Office Request Form
  • Appendix B: Suggested Format for the Briefing Document

Clinical trial submissions

• Regulatory requirements for new application and subsequent submissions (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 (updated 1 Mar 2021) 
• Multi-sponsor investigator-initiated trials (updated 1 Mar 2021)
• Chemistry, Manufacturing and Controls Requirements for Cell, Tissue or Gene Therapy Products for Clinical Trials and Product Registration (Appendix 8 of CTGTP registration guide)

Clinical Research Materials

• Clinical Research Materials (updated 1 Mar 2021) 

Subsequent Submissions

• Guidance on determining whether an amendment to a clinical trial is a substantial amendment (updated 1 Mar 2021)
• Expedited safety reporting requirements for clinical trials (updated 1 Mar 2021)
• Notification of serious breach (updated 1 Mar 2021)
• Product defect reporting and recall procedures for therapeutic products and cell, tissue and gene therapy products

Conducting clinical trials

Informed Consent

• Safeguards and consent requirements in vulnerable trial participants (updated 1 Mar 2021)
• Consent requirements for clinical trials involving collection of human tissue (updated 1 Oct 2021)
• Electronic consent (updated 1 Oct 2021)

Investigational Product

• Labelling of investigational and auxiliary products in clinical trials (updated 1 Mar 2021)
• Alternative measures for investigational product management for clinical trials of locally registered products (updated 1 Mar 2021)
• Investigational product repackaging on site (updated 1 Mar 2021)

Good Clinical Practice

• Guidance on Good Clinical Practice compliance inspection framework (updated 13 Sep 2022)

Conduct of clinical trials during a public health emergency

• Guidance on the conduct of clinical trials in relation to the COVID-19 situation (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(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
• S12: Nonclinical Biodistribution Considerations for Gene Therapy Products