How to Register Therapeutic Products in Singapore: HSA Eligibility, Application Types, Evaluation Routes and Pre-Submission Requirements

1. Overview and regulatory context

The Health Sciences Authority (HSA) of Singapore requires all therapeutic products containing chemical or biological active ingredients to undergo registration before they can be marketed. The process ensures quality, safety and efficacy while allowing different pathways depending on the product novelty. This overview page provides the essential pre-submission considerations for regulatory affairs managers planning NDA or generic applications. Source: HSA | Registration overview

2. Who can register and basic eligibility

Only a local company registered with the Accounting and Corporate Regulatory Authority (ACRA) in Singapore is permitted to submit a therapeutic product registration application. Overseas manufacturers are not allowed to apply directly. Source: HSA | Registration overview

3. Pre-submission preparation and key decisions

Before submission, applicants must address three main considerations:

• Select the appropriate application type (New Drug Application – NDA-1, NDA-2, NDA-3 or Generic Drug Application – GDA-1, GDA-2).
• Choose the evaluation route (Full evaluation for NDA only, Abridged evaluation, Verification evaluation, or Verification-CECA for GDA only).
• Decide on the dossier format (International Council for Harmonisation Common Technical Document – ICH CTD or ASEAN Common Technical Document – ACTD). Different formulations, dosage forms, presentations and strengths of the same active entity are treated as separate products requiring individual registrations. Source: HSA | Registration overview

4. Product types and active ingredients

Therapeutic products are classified by their active ingredient type:

• Chemical entity: any chemical element, naturally occurring material or product obtained by chemical synthesis (including peptides, oligonucleotides and microbial metabolites such as antibiotics).
• Biological entity: macromolecules extracted from organisms (proteins, nucleic acids, cytokines, growth factors) or substances from biological systems (whole viruses/bacteria for vaccines, sub-unit vaccines, plasma-derived products, biotechnology-derived polypeptides). Source: HSA | Registration overview

5. Forensic classifications and patent declaration

Applicants must assign one of the following forensic classifications that determine supply controls:

• Prescription-Only Medicines (POM)
• Pharmacy Only Medicines (P)
• General Sale List (GSL) A mandatory patent declaration under regulation 23 of the Health Products (Therapeutic Products) Regulations is required. Specific forms (Appendix 1-Patent Declaration Form 1, Form 2 and Form 3) must be used depending on whether the applicant or patent proprietor is submitting. Source: HSA | Registration overview

6. Overseas manufacturers and GMP requirements

All new overseas manufacturers intending to supply therapeutic products to Singapore after 1 April 2004 must undergo HSA Good Manufacturing Practice (GMP) conformity assessment. Source: HSA | Registration overview

7. Application submission process

Applications are submitted exclusively through the PRISM e-service. Required prerequisites include a CRIS company account and either a Corppass or HSA PIN. Technical support is available via the HSA helpdesk (helpdesk@hsahelp.gov.sg) or hotline 6776 0168 (7:00 am to midnight daily). Source: HSA | Registration overview

8. Last updated date

The registration overview guidance was last updated on 31 December 2018. Applicants should always cross-check the latest version of the full Guidance on Therapeutic Product Registration on the HSA website. Source: HSA | Registration overview