Singapore has emerged as a top destination for clinical trials due to its advanced healthcare infrastructure, favorable regulatory environment, and diverse patient population. Its strategic location in the Asia-Pacific region provides easy access to growing markets. At the same time, the government’s support for clinical research and investment in research infrastructure strengthens its position in the industry.

Despite being one of the smallest countries, Singapore boasts a high standard of living, a strong economy, and a thriving biotech industry, making it a knowledge and skills hub with ample opportunities for research and development.

The Clinical Trial Space in Singapore

The city-state is a hub for clinical research and innovation, focusing on developing new treatments for various diseases and conditions. Its strategic location, skilled workforce, and favorable business environment make it a popular destination for multinational pharmaceutical companies looking to conduct clinical trials in Asia.

Singapore has a strong network of clinical research organizations (CROs) and contract manufacturing organizations (CMOs), which offer a wide range of services to support clinical trials and drug development. This has helped streamline the clinical trial process and reduce costs for companies.

In May 2021, BioNTech announced its plans to establish a regional headquarters for Southeast Asia in Singapore and a fully integrated mRNA manufacturing facility in the same year. This expansion was a significant factor in the country’s position in clinical trial research. The new headquarters and manufacturing facility were expected to create job opportunities and bring substantial investments to the country.

BioNTech has confirmed that its first mRNA manufacturing plant in Singapore will be operational in late 2023 and serve as the German company’s regional headquarters. Located at Tuas Biomedical Park, the facility will be acquired by BioNTech and is part of the company’s strategy to expand its footprint in Asia.

The acquisition of the facility is expected to allow BioNTech to manufacture mRNA-based vaccines and cancer treatments based on its growing pipeline and potentially add other modalities, such as cell therapies.

The facility will play a crucial role in the company’s efforts to develop and manufacture vaccines and therapies for infectious diseases and cancer. This development further reinforces Singapore’s position as a hub for global clinical research and demonstrates the country’s commitment to further developing its capabilities in the industry.

Why is Singapore a good destination for clinical trials?

Singapore is considered a feasible destination for clinical trials for several reasons. The region provides ground due to its:

Favorable Regulatory Environment: Singapore is committed to maintaining high patient safety standards and ethical conduct in clinical trials, which has helped build trust and confidence among patients and healthcare professionals.  The Health Sciences Authority (HSA) is the regulatory body responsible for regulating clinical trials in Singapore.

Efficient Clinical Trial Approval Process: The region has an efficient and streamlined process for approving clinical trials. The HSA aims to provide an initial review within 30 days and a final decision within 60 days of the submission of the application.

World-Class Healthcare Infrastructure: The country’s world-class healthcare infrastructure includes hospitals, clinics, and research facilities. Singapore is known for its advanced medical technology and skilled healthcare professionals. The region is also a leader in precision medicine, focusing on using genomics and other advanced technologies to develop personalized treatments for patients.

Diverse Patient Population: Singapore’s diverse population allows patients from different ethnicities and nationalities to participate in clinical trials. The country’s multicultural makeup includes Chinese, Malay, Indian, and other ethnic groups.

Access to Asia-Pacific Markets: Singapore’s strategic location provides easy access to large and growing markets, including China, India, and Southeast Asia. This makes it an attractive place for global clinical trials.

Government Support: The Singaporean government actively supports clinical research and has invested in research infrastructure and funding programs to encourage research and development in the country.

One example of government support for clinical research in Singapore is the establishment of the Consortium for Clinical Research Institute Singapore (CRIS), a national institute dedicated to building clinical research capabilities and supporting the growth of the clinical research ecosystem in Singapore.

The government has also set up funding programs, such as the National Medical Research Council (NMRC) and the Biomedical Research Council (BMRC), which provide financial support for research projects and initiatives in the healthcare and biotech sectors.

The Singapore government provides funding support for clinical trials through various programs. For example, the National Research Foundation (NRF) provides grants for research and development projects, including clinical trials. The Singapore Clinical Research Institute (SCRI) also provides funding for clinical research projects through its Clinical Research Seed Fund.

What are the obstacles to import compliance for clinical trials in Singapore?

However, importing clinical trial goods into the region is not without its complexities. Several trade constraints can affect the import of goods for clinical trials, including:

Customs Procedures: As is the case for most countries, importing goods into Singapore requires compliance with customs procedures, which can involve additional documentation and inspections. To ensure compliance with local regulations, there are several steps that you may need to adhere to. These include:

1.     Import and export permits: All clinical trial materials imported or exported must be accompanied by the relevant permits, which can be obtained from the Health Sciences Authority (HSA) or the Singapore Customs, depending on the type of material.

2.     Customs clearance: All clinical trial materials imported or exported must go through customs clearance. Importers or exporters should work with qualified partners and third-party service providers to ensure compliance with customs regulations.

3.     Temporary importation: Clinical trial materials can be imported into Singapore temporarily without paying customs duty or goods and services tax (GST). The temporary importation period is up to six months and can be extended with approval from the relevant authorities.

4.     Special provisions for biological materials: Biological materials, such as blood and tissue samples, require special handling and storage conditions. Importers or exporters of biological materials should work with experienced companies or third parties to ensure the efficient handling of such materials.

5.     Re-exportation: Clinical trial materials no longer needed can be re-exported from Singapore. The re-exportation process requires the relevant permits and customs clearance.

6.     Good Distribution Practice (GDP): All clinical trial materials must comply with the GDP guidelines for medicinal products. This includes requirements for storage, transportation, and handling of the materials.

As an example, clinical trial materials (CTMs) imported for use in a clinical trial must be declared to the Health Sciences Authority (HSA) of Singapore before arrival. The importer must also ensure that the CTMs are correctly classified and labeled and that all necessary permits and approvals are obtained. Additionally, the HSA may inspect the CTMs upon arrival to ensure compliance with regulatory requirements. These procedures can add to the time and cost of importing goods for clinical trials in Singapore.

Tariffs and Taxes: Importing goods into the region can be subject to tariffs and taxes, which can add to the cost of conducting clinical trials. This can be particularly challenging for smaller companies or those with limited resources. In Singapore, clinical trial goods are subject to customs duties and goods and services tax (GST) unless they qualify for an exemption or relief.

• Customs Duties, which are levied on goods imported into Singapore. The duty rates vary depending on the classification of the goods under the Harmonized System (HS) code. The duty rates are typically zero-rated for clinical trial goods, but it is advisable to check with Singapore Customs to confirm the specific HS code and applicable duty rate.

• Goods and Services Tax (GST) is a value-added tax imposed on the importation and supply of goods and services in Singapore. The current rate of GST is 7%. Clinical trial goods may qualify for GST relief if they meet certain conditions.

If the clinical trial goods meet the above conditions, they may be eligible for GST relief under the Import GST Deferment Scheme for Approved Clinical Trials. The scheme allows approved entities to defer the payment of GST until the goods are supplied to the clinical trial site or the trial is completed.

Intellectual Property Rights: the country has strong intellectual property laws, which can protect clinical trial sponsors from infringement. However, it can also make it challenging to import certain products protected by patents or other intellectual property rights and limit the availability of certain drugs or devices for use in clinical trials.

Trade Agreements: Singapore has signed several trade agreements that support and promote clinical trials in the country. These agreements provide a framework for cooperation between Singapore and other countries in various areas, including trade, investment, and intellectual property. Some of the key trade agreements relevant to clinical trials in Singapore are:

1.     Comprehensive Economic Cooperation Agreement (CECA) with India: The CECA between Singapore and India, signed in 2005, includes provisions for cooperation in healthcare and pharmaceuticals. This agreement facilitates the conduct of clinical trials and promotes the development of new drugs and medical devices.

2.     Trans-Pacific Partnership (TPP) Agreement: Singapore was one of the 12 countries that signed the TPP agreement in 2016. This agreement includes provisions for protecting intellectual property, including patents and trade secrets. This provides a supportive environment for companies conducting clinical trials in Singapore.

3.     European Union-Singapore Free Trade Agreement (EUSFTA): The EUSFTA, which was signed in 2018, provides for the protection of intellectual property and includes provisions for cooperation in pharmaceuticals. This agreement also promotes the use of international standards for the conduct of clinical trials.

4.     Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP): The CPTPP, enacted in 2018, is a revised version of the TPP agreement. It includes provisions for intellectual property protection and cooperation in healthcare and pharmaceuticals.

These trade agreements provide a supportive environment for clinical trials in Singapore by promoting cooperation and providing a framework for protecting intellectual property. They also facilitate the exchange of information and expertise between countries, which can benefit the development of new drugs and medical devices.

Regulatory Requirements: They have strict regulatory requirements for the import of pharmaceutical products and medical devices, which can be time-consuming and costly to navigate. These regulations are in place to ensure the safety and efficacy of clinical trial products. The region also has strict clinical trial import requirements relating to regulations, including requirements for ethical review, informed consent, and safety reporting.

These requirements can be particularly arduous for companies conducting trials in multiple countries.  For example, In Singapore, both Importer of Record (IOR) and Exporter of Record (EOR) requirements are applicable for clinical trials.

Importer of Record (IOR) and Exporter of Record (EOR) Requirements: When conducting clinical trials, it is crucial to appoint a registered company in Singapore as the Importer of Record (IOR) and Exporter of Record (EOR) to comply with all import and export regulations. The IOR is responsible for clearing goods through customs, while the EOR is responsible for the exportation of goods, both ensuring compliance with relevant regulatory requirements.

To comply with regulations, the IOR and EOR must be registered companies in Singapore and possess valid customs licenses. Additionally, they must ensure that goods comply with all necessary regulatory requirements and obtain any required licenses or permits. Both parties must ensure that all documentation related to import and export is complete and accurate, including details of shipment contents, goods value, and relevant regulatory documents. Furthermore, they must ensure that all taxes and duties are paid following Singaporean law.

It is important to note that requirements may vary depending on the clinical trial and goods being imported or exported. Therefore, sponsors and clinical trial investigators should consult with relevant regulatory authorities and customs officials to ensure compliance with applicable regulations. By appointing registered companies with necessary licenses and permits as IOR and EOR and ensuring compliance with regulations, the clinical trial process can run smoothly and efficiently.

Import Restrictions: Singapore also has strict import restrictions on certain goods, including pharmaceuticals and medical devices. Clinical trial sponsors may face challenges obtaining the necessary approvals and permits to import these goods into the country.

Overall, the trade limitations in Singapore can pose significant challenges for clinical trial sponsors, particularly those operating globally.

It is important for sponsors to carefully consider these limitations by complying with these requirements and working with local partners and experts to navigate the regulatory and legal landscape.

The TecEx Medical Solution

It’s always a safe bet to partner with a company that understands the fundamentals of the constantly shifting trade compliance parameters and clinical trial import regulations. Since clinical trials require importing and exporting medical equipment and products, navigating the regulatory landscape can be complex and time-consuming.

Therefore, a reliable and experienced Importer of Record (IOR) and Exporter of Record (EOR), such as TecEx Medical, can be an essential service for companies conducting clinical trials in Singapore. TecEx Medical specializes in managing the logistics of medical equipment and products, ensuring compliance with regulatory requirements, and reducing the risk of delays or customs issues.

Singapore offers a robust clinical trial ecosystem with strong government support, world-class infrastructure, and a favorable regulatory environment. Companies conducting clinical trials in Singapore can benefit from the country’s strategic location, diverse patient population, and emerging markets while partnering with an experienced logistics provider such as TecEx Medical can help ensure a seamless and compliant clinical trial process.