Singapore: HSA Tightens Therapeutic Product Registration (effective 30 July 2025)

As part of its ongoing efforts to streamline regulatory processes and ensure better clarity for applicants, the Health Sciences Authority (HSA) introduced important updates to therapeutic product registration requirements. These changes took effect on 30 July 2025.

1. Enhanced Application Checklists

HSA has revised its application checklists to make submission requirements clearer and more comprehensive, affecting both New Drug Applications (NDA) and Major Variation (MAV) routes. Related checklists that have been updated can be checked via the link below.

These enhancements help applicants ensure full compliance before submitting, minimising incomplete or delayed applications.

2. Strict Screening Prerequisites

HSA now emphasises that all prerequisite documents must be submitted for an application to be accepted for screening. Any omission means the application will not be accepted, enhancing the rigour and clarity of early-stage reviews.

3. Updated GMP Compliance Acceptable Proof for Product Manufacturing Sites

According to the latest revision, the acceptable forms of Good Manufacturing Practice (GMP) compliance documentation have been updated to align with the latest “GMP Conformity Assessment of an Overseas Manufacturer (ver. December 2024). Specifically acceptable proof now includes:

• Valid PIC/S GMP Certificate (Certificate of GMP Compliance), or,

• US FDA Establishment Inspection Report (EIR) coupled with a close-out letter

  
  

Crucially, these proofs must be valid at the time of submission and still have at least six months remaining before expiry. This requirement applies to NDA, GDA, and MIV-1/2 applications.

4. Updated Core Guidance Document

The latest version of the “Guidance on Therapeutic Product Registration in Singapore” was updated on 30 July 2025, providing a detailed framework covering everything from a general overview to submission protocols, evaluation routes, and post-approval requirements.

This core document outlines categories such as NDAs, GDAs, biosimilars, evaluation routes (full, abridged, and verification), and dossier requirements, in addition to discussing classification types, including Prescription-Only (POM), Pharmacy-Only (P), and General Sale List (GSL) medicines.

5. Labelling Guidance: Appendix 7 Updated

Labelling requirements have also been sharpened in the updated Appendix 7: Points to Consider for Singapore Labelling. Key areas include:

• Information on outer carton and inner/blister labels

• Machine-readable codes (QR codes, barcodes) for e-labelling

• Instructions for reconstitution, diluent descriptions, and clarity on the route of administration

• Details on excipients, container systems, overdose guidance, and more

  
  

Pharmaceutical companies must work closely with packaging designers and medical writers to ensure labels meet these standards. Even minor inconsistencies can lead to rejection or post-approval amendments.

Stakeholders are advised to perform a labelling compliance check against Appendix 7 for all current and upcoming products, and prepare to implement machine-readable codes into already in place.

Summary Insight

These updates collectively raise the bar for regulatory submissions in Singapore. While they may seem stricter, the ultimate goal is to streamline review processes, reduce avoidable errors, and safeguard patient safety. Companies that adapt early will benefit from faster approvals, fewer resubmissions, and stronger market confidence.

Source: Health Sciences Authority (HSA)