Singapore Pharmaceutical Registration: What You Need to Know

Market Overview

Singapore pharmaceutical registration is becoming increasingly important as the country strengthens its role as a regional pharma hub. The market was valued at approximately USD 7.40 billion in 2024 and is projected to nearly double to USD 12.19 billion by 2033, with a CAGR of 5.5%.

The pharmaceuticals market revenue is expected to grow from USD 1.82 billion in 2025 to USD 2.42 billion by 2030, particularly buoyed by oncology treatments with a CAGR of 5.86%.

This underscores Singapore’s rising importance as a pharmaceutical hub for both innovative and generic medicines, supported by strong regulatory oversight and government R&D investment.

Singapore hosts world-class manufacturing facilities, cutting-edge research institutes, and the Health Sciences Authority (HSA) the country’s regulatory body responsible for ensuring the safety, efficacy, and quality of drugs, medical devices, and health products.

Singapore Pharmaceutical Registration: Product Classification (HSA) 

Therapeutic Products (TPs): Prescription-only, pharmacy-only, and general-sale (OTC) medicines (small molecules and biologics).

Application Types:

• NDA: New Drug Application for novel entities/indications.
• GDA: Generic Drug Application; requires bioequivalence data.

Evaluation Routes (where eligible):
Full, Abridged, Verification, and Verification CECA increasingly leveraging approvals from reference authorities to accelerate reviews.

Registration Process Flow

1. Determine Product Scope & Pathway
2. Appoint Local MAH
3. GMP & Quality Readiness
4. Prepare Dossier
5. Submit Online via PRISM
6. HSA Screening & Evaluation
7. Approval & Listing
8. Post approval Changes

• Determine Product Scope & Pathway: Identify TP class and choose NDA/GDA and Full/Abridged/Verification/Verification CECA route. TPs already approved by reference agencies, verification or abridged routes can be available for quicker and smoother approval
• Appoint Local MAH: A Singapore-registered company serves as the Marketing Authorization Holder and HSA interface.
• GMP & Quality Readiness: Ensure manufacturing facilities meet GMP; provide evidence (e.g., inspection reports). Also, a valid PICs (Pharmaceutical Inspection Co-operation Scheme) GMP certificate can be incorporated, if available.
• Prepare Dossier (ICH CTD/ACTD): Modules 1–5, incorporating Singapore-specific labeling (SGPI/PIL), pharmaceutical development, process validation, manufacturing sites, risk management etc. where applicable.
• Submit Online via PRISM: File application, pay fees, and upload documents via PRISM. Based on the variants, each dosage form and strength require a separate.
• HSA Screening & Evaluation: Conduct administrative and scientific review; manage queries within stipulated timelines. The HSA drug approval Singapore process may also involve additional technical or administrative information requests.
• Approval & Listing: Upon drug registration Singapore, companies can secure product licenses, finalize labeling, and fulfill post-approval obligations (variations, safety reporting, renewals).
• Post approval Changes: Applicant’s keep the HSA informed on any changes to the TP (quality, safety and efficacy) throughout the product lifecycle.

Freyr’s Case Study: Registration Support for an Intravenous Product in Singapore 

Context:

 A U.S.-based company sought rapid approval of an intravenous product (intravenous artesunate) in Singapore.

Services Provided

• Regulatory planning: feasibility assessment, registration strategy for HSA, and dossier scoping.
• Documentation gap analysis.
• Preparation of Module 1.
• Application filing via PRISM and monitoring.
• Uploading of documentation (all modules) into PRISM and splitting/processing of files and their size as per HSA requirements.
• Compilation of query responses and uploading into PRISM
• Liaison and follow-up with HSA.
• MAH services and query resolution.

Challenges

• Demonstrating product quality, safety, and efficacy.
• Coordination across multiple regulatory jurisdictions.
• Meeting Singapore-specific regulatory requirements.

Solution Offered

• Tailored regulatory strategy with a dossier roadmap.
• Detailed gap analysis and high-level document review.
• Compilation and submission of required documents.
• Rapid response to HSA queries and ongoing support through approval.

Benefits

• Accelerated registration due to comprehensive and accurate submissions.
• Cost and time savings through compliance alignment.
• Increased likelihood of approval.
• Efficient query resolution with technical/regulatory expertise.
• Full MAH support until approval.
• On-demand regulatory support as needed.

Summary Table 

Conclusion

Freyr’s expertise in Singapore pharmaceutical registration — from dossier preparation to HSA liaison — enables pharma companies to streamline submissions, accelerate approvals, and gain a competitive edge in this dynamic market. Contact Freyr today.