How therapeutic products are regulated by HSA

Therapeutic Products, Therapeutic products (medicines)

All therapeutic products must be evaluated and approved by HSA before they can be sold in Singapore. Any company that wishes to supply a therapeutic product in Singapore must make an application to HSA and submit scientific data to demonstrate that the product meets the required standards of quality, safety and efficacy. HSA conducts scientific review of these data to ensure that the benefit of the treatment outweighs the risk of side effects before the product is registered.

Access to therapeutic products is calibrated based on the risk profile of the product and the degree of medical supervision required for managing the medical condition being treated.

Classification Who can supply them? Examples of medicines
Prescription-Only Medicines Must be prescribed by a doctor and may be purchased from clinics. A specific list of POMs may also be purchased from pharmacies with a doctor's prescription. Potent medicines which require medical supervision and monitoring, especially when used long term for chronic medical conditions such as diabetes, high blood pressure and high cholesterol.
Pharmacy-Only Medicines (P Medicines) Can be obtained from a pharmacist. A doctor’s prescription is not required. Medicines for minor ailments such as allergic rhinitis, cough, diarrhoea, nausea, hair loss and medicines to help quit smoking.
General Sale List Medicines Can be obtained off-the-shelf from pharmacies, clinics, retail outlets. Sale of these medicines is not restricted because they are safe for use without medical supervision, when used according to the instructions. Medicines such as paracetamol for fever and headache, and antacids for heartburn and acid indigestion.

HSA regularly reviews the control for therapeutic products to enable safe and effective medicines to become more accessible, such as from a pharmacist or off-the-shelf for self-medication. There are measures in place to safeguard public health and ensure appropriate use of medicines, which include:

  • Supply of Pharmacy-only medicines by pharmacists must be properly recorded, and must contain the following details: condition which you are seeking treatment for, your name, identity card number and contact details.
  • Medicines should be accompanied by Patient Information Leaflets (PILs), which contain important information on the use of the medicines and what to look out for when taking them.

What happens before a therapeutic product is approved for sale

HSA's team of regulatory specialists, including scientific and medical experts, studies information submitted by pharmaceutical companies, such as:

  • Available data and evidence obtained from clinical studies
  • Processes and controls in the manufacture of the therapeutic product

This information allows HSA to make detailed assessments regarding the ingredients in the product, how effectively the product works for the intended purposes, and the severity of side effects.

Approval is granted for the medicine to be placed on the market only after HSA concludes that the potential benefits of taking the medicine outweigh the likely risks.

HSA also imposes rigorous standards regarding the manufacture, distribution and supply of therapeutic products:

  • All local therapeutic product manufacturers and distributors must be licensed by HSA.
  • Audits are conducted at local manufacturing and distribution facilities to ensure they comply with the required regulatory standards.
  • For therapeutic products manufactured overseas, the manufacturing plants must be approved by their respective regulatory bodies before the products are allowed for use in Singapore.
  • New overseas manufacturers who intend to register their medicines in Singapore are subject to a Good Manufacturing Practice (GMP) Conformity Assessment by HSA. The manufacturers are assessed for their conformance to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP standard or equivalent through either documentary evidence assessment or an on-site GMP audit.

What happens after a therapeutic product is approved for sale

Some medicines may have rare adverse reactions (side effects) that are not known or documented prior to the registration and licensing of the product. These post-market activities are carried out to monitor the continued safety, quality and efficacy standards of medicines in the Singapore market:

  • Investigation and surveillance - Routine compliance and quality checks are conducted on marketed products and investigations are initiated based on public feedback.
  • Adverse Drug Reaction Monitoring Programme - Local healthcare professionals actively report adverse drug reactions to HSA. HSA also reviews scientific literature, company reports and safety signals detected by international drug regulatory authorities.

In the event that the benefit versus risk profile of the medicine changes, HSA can initiate various courses of actions such as instituting label changes to enhance warnings or requesting companies to withdraw the medicine from the market.

Personal responsibility of consumers

Even with all the above measures in place, consumers should take responsibility for the safe use of therapeutic products by following the points below:

  • Seek advice from a healthcare professional regarding your medical condition.
  • Read the labels and PILs on medicines carefully, and take and store the medicines as directed.
  • Purchase your therapeutic products from reliable sources.
  • Consult a healthcare professional if you experience adverse effects after taking the therapeutic products as directed.