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This application is a service of the Singapore Government.

Health Sciences Authority

Overview

western_medicines_overview

The Therapeutic Products Branch (TPB)  performs the evaluation for therapeutic products (commonly known as western medicines) to ensure that they meet the required standards for quality, safety and efficacy for use in patients in Singapore. This serves to protect and advance the health of our public while facilitating timely access to innovative therapies that are critical for medical needs in Singapore.  

TPB also performs on-going review on the access control (also known as forensic classification) for therapeutic products to enhance public access to safe and effective therapeutic products. Currently there are three classifications:

  • Prescription Only Medicines (POM): a therapeutic product that can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a doctor or a dentist
  • Pharmacy Only Medicines (P): a therapeutic product that can be obtained from a pharmacist at a retail pharmacy
  • General Sale List (GSL): a therapeutic product that can be freely obtained from any retailer

It is possible for a therapeutic product that is initially classified as POM to be reclassified to a P, or subsequently to GSL, upon review that the therapeutic product can be safely and appropriately used by public without medical supervision.

The main activities carried out by TPB include:

  • Evaluation and approval of new and generic therapeutic products
  • Post-approval evaluation of therapeutic products throughout the product’s life cycle
  • Reclassification of therapeutic products
  • Approval for special access to unregistered therapeutic products

 

Frequently Used Links

RegBasics

Registration Basics

Guidelines on Therapeutic Product Registration
Guidance documents, checklists and templates

Fees

Target Processing Timelines
Screening and evaluation timelines for product applications


AppTools

Application Tools

PRISM
Submit and manage application and licenses

Online Therapeutic Products Search

MIV Enquiry Form with Self-guided algorithm
Determine the classification of variation applications before submission


Updates

Updates

New Drug Approvals
Monthly updates on new approvals (new medicinal products, new indications) by HSA

Reclassified Medicines
Updates on reclassification of medicines and information for pharmacists


SafetyReporting

Safety Reporting

Adverse Event Reporting
Reporting adverse events