Regulatory overview of clinical trials
Understand the regulatory framework of clinical trials, clinical research materials and active ingredients used in its manufacturing, under the Health Products Act and the Medicines Act.
Last updated 30 April 2026
Regulation 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 in Singapore
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 subject to regulatory approval by HSA. This applies to all such clinical trials except for observational clinical trials, which are research studies where:
The product is prescribed by a qualified practitioner to a patient in the usual manner in accordance with the terms of the product registration or product licence.
The decision to prescribe the product to the patient is clearly separated from the decision to include the patient in the trial.
The assignment of any patient involved in the trial to a particular therapeutic strategy in which the product is used is not decided in advance by a protocol but falls within the current practice of the qualified practitioner carrying out the trial.
Clinical trials of medical devices or Class 1 CTGTPs, and observational clinical trials are required to comply with the requirements of the Human Biomedical Research Act, regulated under the Ministry of Health. Refer to clinical trials of medical devices for more information.
This table summarises the key regulations and submission routes for clinical trials in Singapore.
List of product types, key regulations and submission routes for clinical trials
Product type | Key regulation | Submission routes (click for more details) |
|---|---|---|
Health Products Act and Health Products (Clinical Trials) Regulations | ||
Medicinal products | ||
Not available NB: Refer to MOH’s Human Biomedical Research Act page 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 CTC [PDF, 448KB]. If still unsure, the sponsor may send an enquiry to HSA_CT@hsa.gov.sg.
If you wish to manufacture, import or supply therapeutic products, CTGTPs, medicinal products or medical devices in a clinical trial, please refer to the next section on regulation of clinical research materials for more details.
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 research participant in accordance with the research protocol or for a clinical purpose.
The manufacture, import and supply of CRM in Singapore must comply with the respective regulatory controls for CRM, which are summarised in the table below.
List of product types and key regulations for CRM
Product type | Key regulations for CRM |
|---|---|
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 |
CRM notification
To facilitate access to CRM for local clinical research use, dealers' licences for the manufacture, import and wholesale supply of CRM, and product registration/ notification 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:
Locally registered CRM which are either
Obtained from local authorised sources (e.g., local distributors, retail shops), or
Imported for local clinical research use via a valid importer’s licence, or
Supplied by its local manufacturer for local clinical research use via 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
Minimally manipulated* CTGTP CRM which are either
Imported for local clinical research use by a known importer*, or
Supplied by its known manufacturer* for local clinical research use
*These terms are further defined as:
“Minimally manipulated” refers to any processing of the cell or tissue stated below that does not alter the cell's biological characteristics or functions, or the tissue's structural properties: cutting or sizing, grinding, shaping, centrifugation, soaking in an antibiotic or antimicrobial solution, sterilisation or irradiation, cell separation, concentration or purification, filtration, lyophilisation, freezing, cryopreservation or vitrification.
“Known importer” refers to a person who has given notice to HSA under Regulation 7 of the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 to import a minimally manipulated CTGTP, until the notice is refused, withdrawn or cancelled.
“Known manufacturer” refers to a person who has given notice to HSA under Regulation 4 of the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 to manufacture a minimally manipulated CTGTP, until the notice is refused, withdrawn or cancelled.
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 and export these products accordingly:
Therapeutic products: Importer's licence for therapeutic products
Medical devices: Import for re-export approval for medical device
CTGTPs: Import for re-export for CTGTP
The table below summarises the different routes for importing therapeutic product (TP), medical device (MD) and CTGTP for local research use versus overseas research use.
List of regulatory import routes for local and overseas clinical research
Purpose of import | Location of clinical research | Regulatory import route |
For use in clinical research | Local | TP/MD/CTGTP: CRM Notification |
Overseas (import for re-export) | ||
For local laboratory's 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).
If you wish to import / supply active ingredients for use in the manufacture of clinical research materials (CRMs) for use in local clinical research / clinical trial, please refer to next section on regulation of active ingredients used in the manufacture of CRM for more details.
Additional requirements for CRM
If a CRM comprises any of the following substances, there will be additional requirements as indicated in the table below.
List of additional requirements for substances in CRM
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,
|
Poisons | Form A Poisons Licence |
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 letter [PDF, 713 KB] and IMDA's presentation slides [PDF, 619 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. Some examples of their duties and obligations include:
Report CRM non-compliances to HSA
Maintain proper record keeping, labelling and disposal
Ensure CRM complies with the applicable standards or requirements set out by HSA
Report defects to HSA
Report adverse events / effects to HSA
Notify HSA on product recall and corrective actions
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.
In addition, for CRMs which are locally manufactured or imported, 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 email.
Refer to our Guidance on Clinical Research Materials [PDF, 718 KB] for more information.
Submissions for CRM
Click on these links for more details on submissions available for CRM:
Regulation of Active Ingredients Used in the Manufacture of Clinical Research Materials
What are active ingredients
Active ingredient refers to the ingredient that contributes to the intended function of the product.
Supporting ingredients that do not contribute to the intended function of the product (e.g. colouring agents, preservatives, etc.) are not active ingredients, but are considered as inactive ingredients.
Regulation of active ingredients used in clinical research materials
The import and supply of active ingredients for use in the manufacture of clinical research materials (CRMs) for use in local clinical research / clinical trial is regulated by us.
Under the Health Products (Active Ingredients) Regulations, dealer licences are not required for the manufacture, import and wholesale supply of active ingredients for use in the manufacture of CRMs for use in local clinical research / clinical trial. This is provided an active ingredients notification is made to HSA prior to the import or supply of active ingredients, as summarised in the table below.
Scenarios requiring submission of active ingredients notification
Activity | Who should submit active ingredients notification | When active ingredients notification should be submitted |
|---|---|---|
Import of active ingredient(s)
| Importer of the active ingredient(s) | Before importing the active ingredient(s) |
Supply of active ingredient(s) by a local manufacturer of the active ingredient(s)
| Local manufacturer of the active ingredient(s) | Before supply of the active ingredient(s) by the local manufacture of the active ingredient(s) |
You do not need to make an active ingredients notification if you are an importer or manufacturer who already holds a valid licence that allows you to import or supply the active ingredients for use in the manufacture of a health product.
You do not need an active ingredients notification for the following scenarios:
Import of active ingredient(s) for use in the manufacture of CRM for use in local clinical research / clinical trial, if the importer already has a valid importer's licence for active ingredients
Import of active ingredient(s) by the local manufacturer of CRM for use in local clinical research / clinical trial, if the manufacturer has a valid manufacturing licence for the relevant health product
Supply of active ingredient(s) by its local manufacturer for use in the manufacture of CRM for use in local clinical research / clinical trial, if the manufacturer has a valid manufacturing licence for the active ingredients
The local manufacturer of the active ingredients is also the local manufacturer of the CRM, and the active ingredients is used for the manufacture of CRM for use in local clinical research / clinical trial
Click here to find out more information on the application process and documents required for active ingredients notification.