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Regulatory overview of clinical trials

Understand the regulatory framework of clinical trials and clinical research materials regulated under the Health Products Act and the Medicines Act. 

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 productsClass 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:

Product type Key regulation Submission route
Therapeutic products Health Products Act and Health Products (Clinical Trials) Regulations  Clinical Trial Authorisation (CTA) or Clinical Trial Notification (CTN)
Class 2 cell, tissue and gene therapy products
Medicinal products Medicines Act and Medicines (Clinical Trials) Regulations  Clinical Trial Certificate (CTC)

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 via our online feedback form.

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:

Product type Key regulations for CRM
Therapeutic products Health Products (Clinical Research Materials) Regulations 

* Class 2 CTGTPs

* Class 1 CTGTPs for which a manufacturer/ importer/ wholesaler notification has not been made to HSA

Medicinal products Medicines (Medicinal Products as Clinical Research Materials) Regulations 
Medical devices Health Products (Medical Devices) Regulations 

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:

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

Location of clinical research Regulatory import route
Clinical research Local TP/MD: CRM notification
Overseas (import for re-export) TP: Importer's licence for therapeutic products

MD: Import for re-export approval for medical device

CTGTP: Import for re-export for CTGTP

Laboratory analysis of human biological samples from clinical research Local (i.e. samples from local trial participants) MD: CRM Notification
Overseas (i.e. samples from overseas trial participants)

For import of unused therapeutic products from overseas trial sites for local disposal, CRM notification is not applicable. You will need to apply for an importer's licence for therapeutic products for restricted activity, and comply with duties and obligations outlined in the Health Products (Therapeutic Products) Regulations (e.g., record-keeping and ensuring that the product is not supplied to the public). You may also wish to check with the National Environment Agency (NEA) for any other applicable requirements.

Additional requirements

If a CRM comprises any of the following substances, there will be additional requirements as indicated in the table below.

Substances Additional requirements
Controlled drugs and psychotropic substances

Licences for controlled drugs and psychotropic substances

Note: CTA/CTN/CTC and/or CRM notification acknowledgement (as applicable) should be provided in the application for the above licences.

Upon trial completion, any leftover CRM must be destroyed, and the procedure witnessed by a HSA inspector. If the CRM is to be exported, a corresponding export licence should be applied and issued before the export is made.

Poisons
Form A Poisons Licence

Note: CRMs which are therapeutic products are excluded from this requirement.
Radiopharmaceuticals The import, export, possession, use, transport and disposal of radioactive material is regulated under the Radiation Protection Act by the National Environment Agency.

In addition, import of telecommunication devices (e.g. tablets or mobile phones) into Singapore is regulated by the Infocomm Media Development Authority (IMDA). Importers will need to provide information regarding proposed use of devices via the TradeNet's online declaration form or email to IMDA. Please refer to our letter713 KB and IMDA's presentation slides619 KB for more details.

Dealer's duties and obligations

The CRM regulations are intended to ensure supply chain integrity, and prevent the inadvertent or deliberate release of unregistered CRM into the market for use other than in clinical research.

It is critical for all local manufacturers, importers and suppliers of CRM (including local sponsors and investigators) to maintain the integrity of the CRM supply chain through proper record keeping, labelling and disposal.

All local manufacturers, importers or suppliers of CRM must only supply the CRM for use in a clinical research, unless the CRM is locally registered and is manufactured, imported or supplied with a valid dealer's licence. The local sponsor of the clinical research must also ensure that the CRM is only used in a research study approved by an Institutional Review Board (IRB), and in accordance with the research protocol, and must ensure that any unused CRM is disposed or exported within 6 months of study conclusion.

If the local sponsor wishes instead to put such unused CRM to other uses after the clinical research is completed, the sponsor must obtain written permission from us via our online feedback form.

Refer to the following for more information:

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