The Health Sciences Authority (HSA) is Singapore’s national regulatory agency responsible for ensuring the safety, quality, and efficacy of health products, including the oversight of clinical trials. HSA reviews and approves clinical trial applications to ensure compliance with applicable regulatory and ethical standards. All clinical trials involving therapeutic products, Class 2 cell, tissue and gene therapy products (CTGTPs), and medicinal products (e.g., Chinese Proprietary Medicines and health supplements being investigated for the treatment or prevention of disease) are regulated by HSA, except for observational clinical trials.
Overseas sponsors are required to appoint a local representative (e.g., a contract research organisation or local affiliate) that is a business entity registered with the Accounting and Corporate Regulatory Authority (ACRA). This local representative assumes the role of local sponsor and is responsible for all submissions and regulatory correspondence with HSA.
There are 3 types of clinical trial applications: Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN) and Clinical Trial Certificate (CTC). The distinction between the applications can be found in the table below.
| Submission Route | When to apply |
| CTA | A trial investigating one or more locally unregistered therapeutic products or Class 2 CTGTPs, or unapproved use of a locally registered product. |
| CTN | A trial of locally registered therapeutic products or Class 2 CTGTPs used in accordance with their local approved labels. |
| CTC | A trial that investigates one or more medicinal products for the treatment or prevention of diseases in Singapore. |
Institutional Review Boards (IRBs) in Singapore ensure the ethical conduct of clinical trials and safeguard participants’ rights, safety, and welfare. Major IRBs include the SingHealth Centralised Institutional Review Board (CIRB) and the National Healthcare Group (NHG) Domain Specific Review Board (DSRB). IRB applications are typically submitted through the Ethics and Compliance Online System (ECOS).
Application Process and Timeline
In Singapore, Clinical Trial Authorization (CTA) and Clinical Trial Certificate (CTC) applications can be submitted concurrently with the Institutional Review Board (IRB), while a Clinical Trial Notification (CTN) requires IRB approval first. Applications are submitted online through the HSA’s Pharmaceutical Regulatory Information System (PRISM).
| Submission Route | Turnaround Time |
| CTA | 30 working days, or 15 working days for Phase 1 trials solely to evaluate bioequivalence, bioavailability, food effect or drug-drug interactions. 60 working days for Class 2 CTGTP trials. |
| CTN | 5 working days |
| CTC | 30 working days |
| IRB Review | Approximately 45 to 60 working days |
Application Review Fees
There are no application fees for a new Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN), or Clinical Trial Certificate (CTC) in Singapore, nor are fees charged for subsequent updates or amendments following approval.
IRB Review Fees
- Initial application review involving institution(s) from only one healthcare cluster: S$3,000
- Initial application review involving institution(s) from two healthcare clusters: S$4,000
- Initial application review involving institution(s) from three healthcare clusters: S$5,000
- Subsequent amendments (involving protocol and/or informed consent document amendments): S$300
- Subsequent addition of first site from another healthcare cluster: S$1,000/cluster
- Renewal for submission of study renewal/study reactivation report form: S$1,000
Documents Required for Clinical Trial Applications
- Clinical trial protocol
- Informed consent form (in English)
- Investigator’s brochure for locally unregistered products
- Approved product label for locally registered products
- List of overseas trial sites (where applicable)
- Principal investigator’s CV
- Good Manufacturing Practice (GMP) certificate(s)
- Certificate of Analysis (COA) for study batches of investigational products
- Chemistry, Manufacturing and Control (CMC) information, when requested
- GMAC assessment outcome, for CTGTPs or therapeutic products containing genetically-modified organisms (e.g., viral vectors)
- Documents for CRM Notification, if applicable:
- List of components in a medical device system
- Packing list for study-visits specific lab kits, if products in lab kits are not declared in application form
Reference
https://www.hsa.gov.sg/clinical-trials/overview
https://www.hsa.gov.sg/clinical-trials/application/apply-cta-ctn
https://www.singhealthdukenus.com.sg/research/rice/irb-submissions-and-review-fees
Author: Wai Theng Lee, Clinical Research Partnerships Manager
