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.  [1]

Why to choose Singapore for your Clinical Trials?

  • Good infrastructure support like proper drugs storage facilities in the hospitals.
  • Highly qualified doctors and clinical trials coordinators who are trained in Good Clinical Practice (GCP).
  • Highly educated population which understands the risk and benefits of clinical trials.
  • A small geographical country which enables good follow-up.
  • 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.
  • The access to multi-ethnic populations like 74.2 percent Chinese, 13.3 percent Malays, 9.2 percent Indian and Eurasians, and other groups make up 3.3 percent of inhabitants.
  • The ability to rapidly recruit for early-phase studies also ensures shorter trial timelines and, therefore, less overall expenditure.  [2]

Phase I Studies

  • The country plays a 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. [1][2]

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

  • Clinical Trial Authorisation (CTA) – for clinical trials of therapeutic products
  • Clinical Trial Notification (CTN) – for clinical trials of therapeutic products used in accordance with approved label
  • Clinical Trial Certificate (CTC) – for clinical trials of medicinal products

What are the regulatory requirements for clinical trials ?

For clinical trials of therapeutic products (e.g. pharmaceutical drugs and biologics) clinical trial authorisation (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. [3]

Documents required for various Categories

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 sponsor 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 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 authorisation (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 authorisation (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 from study initiation to study completion. [3]

Process Flow

What is the Timeline for Approval?

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. [5]

Fee for regulatory

There are currently no fees imposed for the submission of clinical trial application to HSA. [5]

Import & Export licence

  • 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 prior to import of overseas-manufactured CRM, or prior to supply of locally-manufactured CRM by the local manufacturer. In addition, 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 licence is not required from HSA for shipping of biological samples to overseas for testing. [6]

Still have some questions?

Think about Singapore as a starting point for your Asia-Pacific strategy of clinical development. It can benefit you in several ways.

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References

  1. https://www.lifescienceleader.com/doc/singapore-s-evolution-to-a-top-phase-trial-destination-0001
  2. https://www.scri.edu.sg/wp-content/uploads/2016/03/BioSpectrum-Asia-Sep2013-Clinical-Research-Network-gives-Singapore-its-competitive-edge.pdf
  3. https://www.hsa.gov.sg/content/dam/HSA/HPRG/Clinical_Trials/Guidance/HSA_CTB_Guidance_New_and_Subsequent_Applications_2May2017.pdf
  4. https://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Clinical_Trials/Overview/Regulatory_Guidelines.html
  5. https://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Clinical_Trials/Overview/FAQ.html#b1
  6. https://www.hsa.gov.sg/content/dam/HSA/HPRG/Clinical_Trials/Guidance/HSA_CTB_Guidance_CRM_2May2017.pdf