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This application is a service of the Singapore Government.

Health Sciences Authority

Regulatory Guidance

 

Regulatory Guidance Links
Guidance on Determination of Whether a Clinical Trial Requires a Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN) or Clinical Trial Certificate (CTC) Download.IconPdf 2 May 2017 (574Kb)
Guidance on Regulatory Requirements for New Applications and Subsequent Submissions Download.IconPdf 2 May 2017 (569Kb)
Guidance on Multi-sponsor Investigator-initiated Trials Download.IconPdf 2 May 2017 (361Kb)
Guidance on Clinical Research Materials Download.IconPdf 2 May 2017 (846Kb)
Guidance on Determining Whether an Amendment to a Clinical Trial is a Substantial Amendment Download.IconPdf 2 May 2017 (573Kb)
Guidance on Safeguards and Consent Requirements in Vulnerable Subjects Download.IconPdf 2 May 2017 (656Kb)
Guidance on Labelling of Therapeutic Products and Medicinal Products Used in Clinical Trials Download.IconPdf 2 May 2017 (631Kb)
Guidance on Expedited Safety Reporting Requirements for Therapeutic Products and Medicinal Products Used in Clinical Trials Download.IconPdf 2 May 2017 (573Kb)
Guidance on Notification of Serious Breach Download.IconPdf 2 May 2017 (545Kb)
Guidance on GCP Compliance Inspection Framework Download.IconPdf 2 May 2017 (371Kb)
Guidance on Alternative Measures for Investigational Product Management for Clinical Trials of Locally Registered Therapeutic Products or Medicinal Products Download.IconPdf 2 May 2017 (279Kb)
Guidance for Investigational Product (IP) Repackaging on Site Download.IconPdf 2 May 2017 (399Kb)

 

References Links
Instructions on Adverse Events Reporting for Medical Devices in Clinical Trials Click to access
ICH E6(R2) Guideline for Good Clinical Practice Click to access