Regulatory overview of clinical trials

What is a clinical trial

A clinical trial is a research study of a health product to investigate any of the following in humans:

• Discover or verify its clinical, pharmacological or pharmacodynamic effects
• Identify any adverse effect that may arise from its use
• Study its absorption, distribution, metabolism and excretion
• Ascertain its safety or efficacy

Regulation of clinical trials

All clinical trials of therapeutic products, Class 2 cell, tissue and gene therapy products (CTGTPs) and medicinal products (e.g. Chinese Proprietary Medicines, health supplements that are being investigated for the treatment or prevention of disease), are regulated by us except for observational clinical trials.

Medical device clinical trials are not regulated by us.

Observational clinical trials, Class 1 CTGTP trials, and medical device trials are nevertheless required to comply with the requirements of the Human Biomedical Research Act.

Regardless of whether we regulate the clinical trial, the manufacture, import and supply of therapeutic products, CTGTPs, medicinal products or medical devices used as a clinical research material (CRM) in Singapore must comply with the regulatory controls for clinical research materials.

The table below summarises the key regulations and submission routes:

Refer to our guide on how to submit an application for CTA, CTN or CTC for more information.

To determine whether a clinical trial is regulated by us, please refer to our Guidance on Determination of Whether a Clinical Trial Requires CTA, CTN or CTC498 KB. If still unsure, the sponsor may send an enquiry to HSA_CT@hsa.gov.sg.

Regulation of Clinical Research Materials

What are clinical research materials

Clinical Research Materials (CRM) refer to any registered or unregistered therapeutic product, medicinal product, medical device, applicable cell, tissue and gene therapy product (CTGTP)* or placebo, that is manufactured, imported or supplied for the purpose of being used in clinical research, by way of administration to a trial participant in accordance with the research protocol or for a clinical purpose.

Regardless of whether we regulate the clinical trial, the manufacture, import and supply of CRM in Singapore must comply with the respective regulatory controls for CRM, which are described in the table below:

CRM notification

To facilitate access to CRM, dealers' licences for the manufacture, import and wholesale supply of CRM, and product registration for the supply of CRM are not required. This is provided a CRM notification is made before:

• Import of CRM for local clinical research use
• Supply by the local manufacturer of CRM for local clinical research use, including CRM compounded at the local trial site

You do not need a CRM notification for the following scenarios:

• Locally registered CRM obtained from local commercial sources
• Import of locally registered CRM for local clinical research use if the importer already has a valid importer’s licence for the import of CRM
• Supply of a locally registered CRM by its local manufacturer for local clinical research use if the manufacturer has a valid manufacturer's licence
• Supply of CRM by a local manufacturer if the manufacture of the CRM being supplied comprises solely of the packaging or labelling of the CRM
• Import of a minimally manipulated CTGTP CRM for local clinical research use by a known importer
• Supply of a minimally manipulated CTGTP CRM by its known manufacturer for local clinical research use

For products imported solely for export to overseas trial sites, CRM notification is not applicable. You would need to apply for an approval to import these products accordingly:

• Therapeutic products: Importer's licence for therapeutic products 
• Medical devices: Import for re-export approval for medical device
• CTGTP: Import for re-export for CTGTP

The table below summarises various routes for importing therapeutic products (TP), CTGTP and medical devices (MD) for local research use versus overseas research use.