HSA’s Role in the Regulation of Therapeutic Products in Singapore
All therapeutic products are subject to product registration prior to their sale and supply in Singapore. The safety, quality and efficacy of therapeutic products are scientifically assessed by Health Sciences Authority (HSA) to meet internationally benchmarked standards before marketing approval is granted. These medicines are regulated as Prescription-Only medicines [POM], Pharmacy-Only [P] medicines or General Sale List [GSL] medicines based on the risk profiles of medicines and the appropriate degree of medical supervision required for the management of the medical condition.
No medicine is completely free of risk. Therefore, HSA is also committed to responding promptly when safety, quality or efficacy concerns arise. In line with regulatory systems in many developed countries, all therapeutic products are also subject to HSA's post-marketing surveillance programme which includes regular compliance checks, product sampling and Adverse Drug Reaction (ADR) monitoring to ensure that they continue to meet the required safety, quality and efficacy standards. Products found not to comply with HSA's requirements may be suspended from further sales or recalled from the market.
Different Classes of Therapeutic Products in Singapore
Medicines are substances that are used by consumers and patients for the diagnosis, treatment, or prevention of a disease. The range of western medicines available in the Singapore market is classified into 3 main groups
|Prescription Only Medicines (POM)||These comprise potent medicines which require medical supervision and monitoring, especially when used long term for chronic disease conditions. They can only be prescribed by doctors and are available from clinics or may be purchased from pharmacies with a doctor's prescription.||Medicines for chronic diseases such as:
|Pharmacy Only Medicines (P Medicines)||These are usually medicines that are used for the management of minor ailments. They can be purchased from pharmacists without a doctor's prescription. Consultation with pharmacists is required to determine the appropriateness of treatment.||Certain medicines for conditions such as:
|General Sales List Medicines (also known as Over-the-Counter Medicines)||These are medicines whereby sale is not restricted because they are deemed safe for self medication without medical supervision by a doctor or a pharmacist when used appropriately and according to the instructions.||
How Therapeutic Products are Regulated in Singapore
Purchasing Medicines from the Pharmacy in the presence of a Pharmacist
Besides P medicines, some POMs have been assessed by HSA to be suitable to be supplied by pharmacists without a prescription, when specified conditions are met.
HSA has taken proactive steps to review these drugs on a regular basis. This is intended to enable such medicines that have been already deemed sufficiently safe for use under reduced medical supervision, to be made more readily available by allowing them to be directly purchased from a pharmacist without a prescription. Please refer to the Reclassified Medicines webpage for the list of POM with exemptions for supply without a prescription.
These medicines are usually for the management of minor ailments and can only be purchased from the pharmacy in the presence of a pharmacist. While allowing for greater access by public, HSA also wants to ensure safe and appropriate use of medicines by introducing:
1) Recording of medicines purchased from the pharmacist:
From 1 April 2011, HSA has implemented the requirement for record-keeping in phases when purchasing medicines from the pharmacist. The following details are required of the public taking the medicine: Information of the condition which he/she is seeking treatment for, name, identity card number and contact details (address, contact number or email).
Documentation of each supply of medicine by the pharmacist would:
- Ensure safe and appropriate use of medicines
- Allow pharmacists to follow up with the public when there are any concern.
2) Patient Information Leaflets
Patient Information Leaflets (PILs) are usually supplied with Pharmacy-only or General sales list medicines. The PILs contain important information on the use of the medicine and what to look out for when taking it. These include:
- What is the medicine used for?
- How to take the medicine?
- Does food have any effect on how the medicine works?
- Is the medicine safe on pregnant women, breastfeeding mothers, the elderly or children?
- Is it safe to take the medicine if one has existing medical conditions?
- Are there any side effects to be expected when taking the medicine?
- How to store the medicine?
These PILs are written in simple terms for the public to understand the medicines they are taking and to watch out for side effects. It is advisable to take time to carefully read and understand the PILs. Always seek advice from a pharmacist or doctor if in doubt.
Before a therapeutic product is approved for sale in the Singapore market:
- HSA's team of regulatory specialists (consisting of 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 medicine
- This information allows HSA to make detailed assessments regarding the ingredients in the medicine, how effectively the medicine works for the intended purpose(s), and the severity of side effects.
- Approval is granted for the medicine to be placed on the market only after HSA is satisfied that the potential benefits of taking the medicine outweigh the likely risks for the intended uses of the medicine. HSA engages external experts and Medicine Advisory Committees at certain times to complement the internal review process.
HSA also imposes rigorous standards regarding the manufacture, distribution and supply of the medicine through the following:
- All local medicine manufacturers and distributors must be licensed by HSA.
- Audits at local manufacturing and distribution facilities to ensure they comply with the required regulatory standards.
- For medicines manufactured overseas, the manufacturing plants must be approved by their respective regulatory bodies before the products are allowed for use in Singapore.
In addition, since April 2004, all 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.
After a therapeutic product is approved for sale in the Singapore market:
No medicine is completely free of risk, and some medicines may have rare adverse effects that are not known or documented prior to the registration and licensing of the product. As such, in addition to the rigorous pre-approval processes, HSA continues to monitor the safety and quality of medicines and takes swift corrective actions when necessary to safeguard public health.
Hence, a range of post-market activities are carried out by HSA to monitor the continued safety, quality and efficacy standards of medicines on sale in the Singapore market. These include:
i. Investigation and surveillance
Investigation & surveillance, where routine compliance and quality checks are conducted on marketed products and also investigations into public feedback are conducted.
Products that do not meet stipulated standards or found to pose risks to members of public may be suspended from further sales or recalled from the market.
Manufacturers or distributors who are found to have flouted laws governing western medicines are liable to be prosecuted.
ii. ADR Monitoring Programme
HSA's ADR Monitoring Programme draws on the network of local healthcare professionals, who actively report adverse drug reactions to HSA, and from the international network of national regulators to detect adverse effects and defects relating to health products. HSA's officers review scientific literature, company reports and safety signals detected by other drug regulatory authorities to ensure that the benefit-risk profile of the medicines continues to remain favourable after they are marketed in Singapore. This programme aims to detect significant safety signals that may arise so that appropriate actions can be taken to protect public health and safety.
In the event that the benefits versus risks 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.
Even with all these measures in place, consumers should take personal responsibility for the safe use of medicines by:
- seeking your healthcare professional's advice regarding your condition
- taking and storing your medicines as directed
- purchasing your medicines from reliable sources
- reading the labels on medicines carefully, including the PILs
- consulting a healthcare professional if you experience adverse effects after taking the medicines as directed