Drug Registration & Approval Process In Singapore
The regulatory and approval of drugs in Singapore is a rigorous and comprehensive process. This is to ensure the safety, quality, and efficacy of drugs sold in the country. Although the process may be complex and time-consuming, people generally consider it transparent, predictable, and science-based.
The significant market for therapeutic products in Singapore is expected to continue growing in the coming years. The country has a well-developed healthcare system, with a strong emphasis on R&D, and a high standard of medical care.
Singapore’s aging population, growing incidence of chronic diseases, and increasing demand for advanced medical treatments are driving demand for therapeutic products.
A report states that the Singapore therapeutics market had a value of USD 10.6 billion in 2020. The report also expects to grow at a compound annual growth rate (CAGR) of 5.6% from 2021 to 2028. The report cites factors such as
- increasing healthcare expenditure,
- growing incidence of chronic diseases, and
- increasing government initiatives to support the development of the healthcare industry
as drivers of this growth.
The Singapore government has been proactive in developing the country’s pharmaceutical industry. It offers incentives to attract multinational pharmaceutical companies to set up operations in Singapore.
The regulatory authority for drug registration in Singapore
The regulatory authority in Singapore for therapeutic products such as drugs, medical devices, and traditional Chinese medicine is the Health Sciences Authority (HSA).
- The Ministry of Health in Singapore oversees the HSA, a statutory board that regulates health products.
- The HSA has established specific guidelines and requirements for each stage of the approval process.
- The manufacturers and importers must follow to ensure compliance with local regulations.
Classification of therapeutic products in Singapore
Therapeutic products in Singapore are classified into several categories based on their intended use, risk level, and mode of action. The Health Sciences Authority (HSA) has established a classification system for these products as below.
- Conventional drugs: This category includes synthetic chemical drugs, biologics, and vaccines. Conventional drugs are further classified into prescription drugs and over-the-counter (OTC) drugs based on their risk level and the need for medical supervision.
- Traditional Chinese Medicine (TCM): This category includes products derived from natural sources. These include plants, minerals, and animal products, and are used in accordance with TCM principles.
- Health supplements: This category includes vitamins, minerals, herbal products, and other natural substances used to supplement the diet.
- Medical devices: This category includes devices used to diagnose, prevent, or treat diseases or medical conditions, such as diagnostic imaging equipment, surgical instruments, and implantable devices.
- Complementary and alternative medicine (CAM): This category includes products and practices used to complement or replace conventional medical treatments, such as acupuncture, homeopathy, and naturopathy.
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What are the requirements for drug registration in Singapore?
To register drugs/medicines in Singapore, the Health Sciences Authority (HSA) requires the following information and documentation:
- Drug Master File (DMF): If applicable, the sponsor shall need to submit a DMF to the HSA. The DMF contains confidential information on the drug substance, drug product, or manufacturing process.
- Quality information: The applicant must provide detailed information on the quality of the drug, including the manufacturing process, analytical methods, and specifications.
- Non-clinical data: Non-clinical data on the drug’s pharmacology, toxicology, and pharmacokinetics must be provided.
- Clinical data: To demonstrate the drug’s safety and efficacy, the applicant must provide clinical data from well-controlled trials. This data shall meet the requirements for the specific type of application and be generated using good clinical practices.
- Product information: The applicant must provide information on the drug’s labeling, package inserts, and patient information leaflets. This information should be consistent with the approved labeling in other countries and comply with local regulatory requirements.
- Manufacturer’s authorization: The applicant must provide evidence that the manufacturer has authorized the application and that the manufacturing facilities comply with Good Manufacturing Practices (GMP).
- Fees: The applicant must pay the required fees for the application and any related services.
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Steps involved in registering drugs in Singapore
Registering drugs/medicines in Singapore involves several detailed steps. Here are the following steps.
- Pre-submission consultation: Before the sponsor submits an application to the HSA, it is advisable to consult with the Health Sciences Authority (HSA) for guidance on the application process and to determine the type of application necessary.
- Application submission: The applicant must submit a complete and accurate application to the HSA through the online submission portal.
- Administrative check: Upon receipt of the application, the HSA will conduct an administrative check to ensure that all necessary documents and fees have been submitted.
- Technical review: The HSA will conduct a technical review of the application, which includes an assessment of the quality, safety, and efficacy of the drug. The review process may take up to 180 working days.
- Site inspection: The HSA may conduct a site inspection of the manufacturing facility to ensure compliance with good manufacturing practices.
- Evaluation and approval: Once the technical review and site inspection is complete, the HSA will evaluate the application and determine whether to approve or reject it. If approved, the HSA will issue a certificate of registration.
- Post-approval obligations: Following registration, the drug should be labeled and marketed in compliance with the conditions specified in the certificate of registration. The applicant must also submit periodic safety reports to the HSA.
What is the process to import drugs after approval in Singapore?
Once the sponsor receives the approval for sale in Singapore from the Health Sciences Authority (HSA), the process for importing the drug into the country involves several steps:
- Importer’s license: The importer must obtain a valid import license from the HSA. The license is valid for one year and requires renewal annually.
- Import permit: Once the drug has been registered with the HSA, the importer must obtain an import permit for each shipment of the drug. The import permit is valid for a specific quantity and period and must be obtained before the drug can be imported.
- Customs clearance: The importer must obtain clearance from Singapore Customs before the drug can be released for sale or distribution. The importer must provide the necessary documentation, such as the import permit and invoice, to clear the drug through customs.
- Distribution and sales: After customs clearance, it can be distributed and sold in Singapore. The importer must comply with all local regulations, such as labeling requirements and advertising restrictions.
It is important to note that the importer is responsible for ensuring that the drug complies with all local regulations and requirements.
The HSA may conduct post-market surveillance activities. This is to ensure that the drug continues to meet the required standards for quality, safety, and efficacy. The importer must also report any adverse reactions or quality defects associated with the drug to the HSA.
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