Singapore Pharmaceutical Registration
Your HSA Gateway
Regulatory . Certification . Licensing . Assurance
Navigate Singapore's robust regulatory framework with confidence. Our Singapore-based team provides comprehensive pharmaceutical registration, HSA marketing authorization, and regulatory compliance services to accelerate your market entry in this strategic Asia-Pacific hub.
Why Singapore
Prime Choice for Pharmaceutical Market Entry
Strategic Business Advantages
Singapore is a prime choice for pharmaceutical companies to register their products due to its strategic location and stable business environment, making it an attractive destination for pharmaceutical companies seeking to register and commercialize their products in the Asia-Pacific region.
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Key Singapore Benefits:
• Strategic Asia-Pacific location and regional hub status
• Stable political and economic environment
• Strong intellectual property protection
• Attractive government incentives for pharmaceutical businesses
Our Singapore Services
Health Sciences Authority (HSA) Excellence
The Health Sciences Authority (HSA) upholds international standards with a robust regulatory framework, ensuring swift and reliable product reviews with efficient approval processes.
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HSA Regulatory Advantages:
• Committed to timely reviews of product registrations
• Enables companies to bring products to market more quickly compared to other jurisdictions
• Adherence to global standards facilitates smoother registration processes
• Recognition of approvals from reputable authorities (U.S. FDA, European EMA)
Attractive Tax Environment
Singapore is also known for its attractive tax system that benefits pharmaceutical companies:
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Tax Advantages:
• Low corporate tax rate structure
• Tax incentives for specific industries (including trading and logistics)
• Extensive network of Double Taxation Agreements (DTAs) with numerous countries
• Relatively low Goods and Services Tax (GST)
• Appeal for international trade and business operations
Ready to Enter Singapore's Pharmaceutical Market?
Let's Navigate Your HSA Registration Success
Don't let regulatory complexity delay your Singapore market entry. Our Singapore-based regulatory experts, with deep HSA knowledge and proven track record, are ready to accelerate your pharmaceutical registration and market access in this strategic Asia-Pacific hub.
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Contact us today to discuss how our Singapore expertise can accelerate your pharmaceutical market success.
Our Experiences
Experienced more in 15 years in handling a wide range of product types, including New Drug Applications (NDA) and Generic Drug Application (GDA) including vaccines, biologics, biosimilars, generics, cosmetics, health supplements, and medical devices.
>30 NDA submissions in Singapore, including biologics, biosimilars, new drugs, generics, vaccines, cosmetics, health supplements, etc.
We offer tailored strategic planning for product registration and regulatory compliance under the Health Sciences Authority (HSA) guidelines on regulatory pathways to meet local market requirements and expedite approvals.
For regulatory submissions and approvals, we provide services for preparation and submission of dossiers in CTD/eCTD format for HSA evaluation. We are able to support on preparing for and undergoing HSA inspections and audits for GDP.
Acting as Marketing Authorization Holder Representation as Regulatory and Local Responsible Person in Pharmacovigilance, liaison with Health Singapore Authority, efficiently handling queries and regulatory communications for MA approval.
Ensuring compliance with HSA requirements for product labels, package inserts, and outer packaging. We can provide advice on specific labelling elements, such as active ingredients, warnings, and local language requirements and assist implementing changes to labeling due to regulatory updates.
On regulatory intelligence, we can monitor updates to HSA guidelines and policies, thus providing real-time insights on regulatory changes and their impact on product registration and compliance.
Managing inquiries and responses from the HSA regarding applications and compliance matters.
Management of post-market requirements, including major and minor variations, adverse event reporting and pharmacovigilance compliance with guidance on post-market surveillance obligations specific to Singapore’s regulatory framework.
Our Establishment
To become a pharmaceutical MA holder or product registration holder (PRH) in Singapore, a local company registered with the Accounting and Corporate Regulatory Authority (ACRA) is required in order to proceed with a therapeutic product registration, cosmetic or medical device application. We are equipped with HSA’s dealer’s license, which is necessary for importing distributing or supplying registered therapeutic products to entities like pharmacies, hospitals, and clinics. We have active user access to the PRISM and trained consultants proficient in navigating and submitting applications via the online portal https://www.hsa.gov.sg/e-services .
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With these requirements in place and the systems we have already established, our consultancy is fully prepared to function as a reliable Marketing Authorization Holder (MAH) or Product Registration Holder (PRH) in Singapore.
Responsibilities of the Product Registration Holder (PRH) in Singapore
The Product Registration Holder (PRH) plays a critical role in ensuring compliance with regulatory requirements throughout the product’s lifecycle. Below are the key responsibilities:
1. Submit applications for the registration, variation, and renewal of therapeutic products to the Health Sciences Authority (HSA). Applicant must ensure accuracy and completeness of the dossier submitted for evaluation while providing necessary supporting documents and respond to HSA queries during the evaluation process.
2. Ensure that the therapeutic product complies with the conditions of its registration. This includes maintaining compliance with labelling, packaging, and product information requirements as per HSA guidelines.
3. Establish and maintain a pharmacovigilance system to monitor product safety such as to report adverse drug reactions (ADRs) and safety issues to the HSA within stipulated timelines and submitting Periodic Benefit-Risk Evaluation Reports (PBRERs) or other required safety reports.
4. Conduct post-market surveillance to ensure continued safety, efficacy, and quality of the product by investigating and addressing complaints or product quality defects reported by consumers or healthcare professionals.
5. Life cycle management of the registered products, e.g. to submit applications for any changes to the product (e.g., formulation, manufacturing site, labelling updates) for HSA approval and ensure timely implementation of approved variations.
6. Coordinate and execute product recalls promptly in the event of safety concerns or regulatory non-compliance by notifying HSA with detailed recall plans and progress reports.
7. Acting as the primary contact point with the HSA for all regulatory matters related to the product and to address regulatory inquiries, inspections, or audits promptly and effectively.
8. Stay updated on regulatory changes and ensure that the product remains compliant with the latest HSA requirements.
Overview of Pharmaceutical Product Registration in Singapore
Pharmaceutical product registration in Singapore is overseen by the Health Sciences Authority (HSA) under the Health Products Act and its subsidiary regulations. The process ensures that therapeutic products meet stringent standards for safety, efficacy, and quality before being marketed locally. The process for registering pharmaceutical products in Singapore involves several key steps, as outlined below:
01
Determine Product Classification
• Products are classified as therapeutic products, biologics, or complementary health products.
• HSA provides specific guidelines to clarify classification and registration requirements.
Module 1: Administrative information and application form.
Module 2: Overview and summaries of quality, safety, and efficacy data.
Modules 3, 4, and 5: Detailed data on quality, preclinical, and clinical studies.
03
Submission of Dossier
• Prepare a dossier in Common Technical Document (CTD) format or eCTD
• Key modules include:
02
Obtain a Local Entity or Appointment of a PRH
• Only a locally registered company can act as the Product Registration Holder (PRH).
• Foreign companies must appoint a Singapore-based PRH to manage product registration and post-approval obligations.
Full Evaluation: For new products with no prior approvals.
Abridged Evaluation: For products approved by HSA-recognized authorities.
Verification Route: For products already approved by HSA-recognized authorities with identical dossiers.
04
Evaluation Routes
• The registration route depends on the product’s novelty and supporting data:
05
Good Manufacturing Practice (GMP) Compliance
• The product’s manufacturing site must comply with GMP standards.
• GMP evidence, such as certificates or inspection reports, is required.
06
Approval and Licensing
• Once approved, the product is issued a Therapeutic Product Registration Certificate.
• The product registration is valid for five years and must be renewed before expiry.
07
Post-Approval Obligations
• Conduct post-market surveillance and pharmacovigilance.
• Report adverse drug reactions and submit periodic safety updates.
• Manage product variations and labeling updates.
Medicinal Product Classification in Singapore
Medicinal products are classified into the following categories:
Therapeutic Products
Health Supplements
Chinese Proprietary Medicines
Traditional Medicines
Cell, tissue and gene therapy products
Registration Requirements for Pharmaceutical Products in Singapore
International
• WHO, ICH, EMA, US-FDA
Regional
• ASEAN Guidelines for Stability Process Validation Variation
• ASEAN Common Technical Dossier (ACTD)
• ASEAN Common Technical Requirements (ACTR)
Local
• Guidance on Therapeutic Product Registration in Singapore
• HSA announcement page for regulatory update
The pharmaceutical product registration process in Singapore involves the following key steps:
01
Determine Product Classification
Proper classification of the product, such as therapeutic product, CTGP, health supplement, traditional medicines or Chinese Proprietary Medicines, is essential.
02
Appoint an Authorized Representative
Foreign manufacturers must appoint a legal entity and local authorized representative to liaise and serve as PRH with HSA.
03
Submit Application via PRISM Online Portal
Applications must be submitted electronically through HSA’s online platform, including the complete product dossier.
04
Evaluation and Review
HSA evaluates the dossier for compliance with safety, quality, and efficacy standards. Additional documents or clarifications may be requested during this phase.
05
Approval and Registration Number Issuance
Upon successful evaluation, a product registration number will be issued by HSA. This registration number allows the product to be legally marketed, distributed, and sold in the Singapore. The product must continue to comply with HSA regulations throughout its lifecycle, including post-market surveillance and reporting.
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Authority Registration Timeline for Pharmaceutical Products in Singapore
Application Type | Product Category | Evaluation Route | Timeline (Working Days) |
|---|---|---|---|
New Drug Application (NDA) | NDA-1, NDA-2, NDA-3 | Abridged | Screening: 50 |
Evaluation: 180 | |||
Verification | Screening: 50 | ||
Evaluation: 60 | |||
Full | Screening: 50 | ||
Evaluation: 270 | |||
Generic Drug Application (GDA) | GDA-1, GDA-2 | Abridged | Screening: 50 |
Evaluation: 240 | |||
Verification | Screening: 50 | ||
Evaluation: 120 | |||
Verification (CECA) | Screening: 50 | ||
Evaluation: 90 | |||
Biosimilar Products | NDA-2, NDA-3 | Abridged | Screening: 50 |
Evaluation: 180 | |||
Verification | Screening: 50 | ||
Evaluation: 60 |
*Subject to change, always refer to the official website for the latest information
Authority Registration Fees for Pharmaceutical Products in Singapore
Application Type | Evaluation Route | Product Category | Fees (SGD) |
|---|---|---|---|
New Drug Application (NDA) | Abridged | NDA-1 | Screening: 610 |
NDA-2 | Evaluation: 11,600 | ||
NDA-3 | Evaluation: 6,030 | ||
Verification | NDA-1 | Screening: 601 | |
NDA-2 | Evaluation: 17,100 | ||
NDA-3 | Evaluation: 6,030 | ||
Full | NDA-1 | Screening: 3,060 | |
Evaluation: 83,100 | |||
Generic Drug Application (GDA) | Abridged | GDA-1 | Screening: 610 |
Evaluation: 4,280 | |||
GDA-2 | Evaluation: 2,450 | ||
Verification | GDA-1 | Screening: 610 | |
Evaluation: 10,600 | |||
GDA-2 | Evaluation: 5,500 | ||
Verification (CECA) | GDA-1 | Screening: 610 | |
Evaluation: 10,600 | |||
GDA-2 | Evaluation: 5,500 | ||
Biosimilar Products | Abridged | NDA-2 | Screening: 610 |
Evaluation: 11,600 | |||
NDA-3 | Evaluation: 6,030 | ||
Verification | NDA-2 | Screening: 610 | |
Evaluation: 17,100 | |||
NDA-3 | Evaluation: 6,030 |
*Subject to change, always refer to the official website for the latest information
How can we help?
• Pre-Market Strategic Consulting and Feasibility Assessment
• Regulatory intelligence and market entry strategy
• Product classification and regulatory gap analysis
• GMP compliance auditing and advisory
• Dossier preparation and submission handling
• Local Entity Support
•Life Cycle Management such as post-market surveillance and pharmacovigilance support
• Pre-submission consultation activity with Health Agency
• Import License Application
• Change of Product Registration Holder
• Ad-hoc Regulatory Affairs Consultation
