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
New Information related to implementation of the Health Product (Therapeutic Product) Regulations (effective 1 November 2016)
Transfer of Legislative Control for Pharmaceutical Products from Medicines Act and Poisons Act to the Health Products Act
As part of HSA’s ongoing initiative to update and streamline the regulatory controls for health products and bring them under a single legislation, the legislative control for pharmaceutical products (conventionally termed as chemical and biologic drugs), has been transferred from the Medicines Act and Poisons Act to the Health Products (Therapeutic Products) Regulations 2016 under Health Products Act (HPA). This group of products has been gazetted under the First Schedule of the HPA as “therapeutic products” with effect from 15 July 2016. The new regulations were implemented with effect from 1 November 2016.
Please click here for an overview of the port-over exercise and its implementation.
The fundamental regulatory regime for pharmaceutical products remains the same, with fine-tuning of certain regulatory measures. Please click here for more information on the key changes.
Frequently Used Links
Guidelines on Therapeutic Product Registration
Guidance documents, checklists and templates
Target Processing Timelines
Screening and evaluation timelines for product applications
Submit and manage application and licenses
MIV Enquiry Form
Enquire about classification of variation applications before submission
New Drug Approvals
Monthly updates on new approvals (new medicinal products, new indications) by HSA
Updates on reclassification of medicines and information for pharmacists
Adverse Event Reporting
Reporting adverse events