Singapore Clinical Trial Regulatory Process
Singapore has a well-established regulatory framework for clinical trials, overseen by the Health Sciences Authority (HSA). The HSA ensures that clinical trials conducted in Singapore adhere to ethical principles and Good Clinical Practice (GCP) guidelines.
This article was last updated on 14/03/23.
Singapore is considered as the R&D pioneer in Asia with highly qualified clinicians, a solid and advanced infrastructure, cutting-edge technology, commitment by the government to become one of the preferred clinical research destinations worldwide.
Singapore is central to the region (South East Asia) and hub of the life sciences industry, acting as a pacesetter to carry out further development across the rest of Asia as an investigation candidate moves through the later phases. Conducting a Phase 1 study in Singapore can help an R&D company learn about the intricacies of performing development activities in Asia.
Why choose Singapore for your clinical trials?
- Robust regulatory framework
- Singapore has a well-developed infrastructure, including state-of-the-art research facilities, hospitals, and clinics, which provide a conducive environment for conducting clinical trials.
- Highly qualified doctors and clinical trial coordinators who are trained in Good Clinical Practice (GCP).
- A highly educated population that understands the risks and benefits of clinical trials.
- A small geographical country that enables good follow-up and efficient monitoring of trial participants.
- Dedicated clinical research units at many key hospitals in Singapore to support clinical trials.
- Singapore has many leading doctors who have set up clinical research networks with other doctors in the Asia Pacific region to conduct multi-center studies.
- Access to a multi-ethnic population, with 74.2 percent Chinese, 13.3 percent Malays, 9.2 percent Indian and Eurasians, and other groups making up 3.3 percent of inhabitants.
- The ability to rapidly recruit participants for early-phase studies, which ensures shorter trial timelines and lower overall expenditure.
Phase I studies
- The country plays an impeccable role in conducting Phase 1 studies in the Asia-Pacific region.
- Many pharmaceutical and biotech companies are now choosing to bring their innovative early-phase trials to Singapore over other conventional options of the United States or Europe. This is largely due to the track record of success stories during the last five years.
Clinical trial regulatory authority in Singapore
The Health Sciences Authority (HSA) regulates the conduct of clinical trials of therapeutic products and medicinal products under the Health Products (Clinical Trials) Regulations and the Medicines (Clinical Trials) Regulations respectively.
The regulations require sponsors of clinical trials to submit details of the clinical trials to HSA under one of 3 submission routes.
| Category | Application Type |
|---|---|
| Clinical trials of therapeutic products | Clinical Trial Authorisation (CTA) |
| Clinical trials of therapeutic products used by approved label | Clinical Trial Notification (CTN) |
| Clinical trials of medicinal products | Clinical Trial Certificate (CTC) |
However, Medical device clinical trials are not regulated by the HSA.
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.
What are the regulatory requirements for clinical trials?
For clinical trials of therapeutic products (e.g. pharmaceutical drugs and biologics), clinical trial authorization (CTA) or acceptance of clinical trial notification (CTN) is required before the trial is initiated or conducted.
For clinical trials of biological products like cell, tissue, and gene therapy products or complementary health products a clinical trial certificate (CTC) is required before the trial can be initiated or conducted.
Clinical trials must be conducted in compliance with the ICH E6 Good Clinical Practice guidelines along with the Medicines (Clinical Trials) Regulations for therapeutic products & Health Products (Clinical Trials) Regulations for Biological products.
Documents required for various Categories
| No. | Documents | Clinical Trial Authorization (CTA) | Clinical Trial Notification (CTN) | Clinical Trial Certificate (CTC) |
| 1 | Clinical Trial Protocol | ✔️ | ✔️ | ✔️ |
| 2 | Informed Consent Form (English) | ✔️ | ✔️ | ✔️ |
| 3 | Investigator’s Brochure | ✔️ | – | ✔️ |
| 4 | List of Overseas Trial Site, where applicable | ✔️ | ✔️ | ✔️ |
| 5 | Principal Investigator’s CV | ✔️ | ✔️ | ✔️ |
| 6 | Good Manufacturing Practice (GMP) Certificate | ✔️ | ❌ | ✔️ |
| 7 | Certificate of Analysis (COA) for study batches of Investigational Products | ✔️ | ❌ | ✔️ |
| 8 | Chemistry. Manufacturing and Control (CMC) information, if requested by HSA | ✔️ | ❌ | ✔️ |
| 9 | Approved Product Label | ❌ | ✔️ | ❌ |
| 10 | IRB Approval Letter | ❌ | ✔️ | ❌ |
What are the regulatory requirements on First-in-Human (FIH) trials of therapeutic products?
The therapeutic product need not be approved in other countries before the FIH trial can be conducted in Singapore. As with all clinical trials, the sponsored applicant must be a locally registered company.
For guidance on non-clinical and clinical requirements, companies may refer to applicable ICH guidelines and relevant guidelines issued by the major agencies (FDA, EMA) [4]
What is the process of approval
- A guidance document gives information about whether a drug belongs to CTA or CTN category
- Once it has been determined that a clinical trial on therapeutic product/s is subject to the requirements of a Clinical Trial Authorisation (CTA) or Clinical Trial Notification (CTN), the sponsor should submit the clinical trial application to HSA.
- Clinical trials of medicinal products like cell, tissue, and gene therapy products or complementary health products are regulated under the Medicines Act and Medicines (Clinical Trials) Regulations. Such clinical trials require a Clinical Trial Certificate (CTC) issued by HSA before the trial can be conducted
- The sponsor should be a locally registered business entity registered with the Accounting and Corporate Regulatory Authority (ACRA) in Singapore. The sponsor should submit the clinical trial application to HSA online via the Pharmaceutical Regulatory Information System (PRISM).
- For clinical trials that require clinical trial authorization (CTA) or a clinical trial certificate (CTC), the clinical trial application can be submitted concurrently to HSA and the relevant IRB. For clinical trials that require clinical trial notification (CTN) to HSA, the submission should be made only after having received IRB approval for the clinical trial.
- Subsequent submissions like Substantial amendments, Serious Breaches, Trial Status Reports, etc to HSA may be required during a clinical trial. All subsequent submissions to HSA should be submitted via PRISM unless otherwise specified.
- When the sponsor gets the approval from HSA, can initiate the trial.
- The authorization (for CTA), or acceptance of notification (for CTN), of the clinical trial by HSA, is valid for the duration of the clinical trial. The duration of the clinical trial refers to study initiation to study completion. [3]
Process Flow
What is the timeline for approval?
The timeline varies with the category to which the trial belongs timelines for various categories are
- Clinical Trial Authorisation (CTA) – 30 Working Days
- Clinical Trial Notification (CTN) – 5 Working Days
- Clinical Trial Certificate (CTC) – 30 Working Days
For CTA Phase 1 clinical trials solely to evaluate bioequivalence, bioavailability, food effect or drug-drug interaction take around 15 days.
Fee for regulatory
There are currently no fees imposed for the submission of a clinical trial application to HSA.
Import & Export license
- The import and supply of therapeutic products, medicinal products and medical devices for clinical research in Singapore are regulated under the Health Products (Therapeutic Products as Clinical Research Materials) Regulations, the Medicines (Medicinal Products as Clinical Research Materials) Regulations, and the Health Products (Medical Devices) Regulations respectively.
- Under these regulations, notification to HSA (CRM – Clinical Research Material Notification) is required before the import of overseas-manufactured CRM, or before the supply of locally-manufactured CRM by the local manufacturer. Besides, local manufacturers, importers, suppliers of CRM, and clinical trial sponsors are required to comply with duties and obligations under the regulations.
- Sponsors of regulated clinical trials submit the CTA/CTN/CTC application form includes the CRM notification.
- Sponsors of non-HSA-regulated clinical research may be required to endorse the CRM notification that is to be submitted by the importer or local manufacturer.
- An export license is not required from HSA for the shipping of biological samples overseas for testing. [6]
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