2. Product Categories

Ingredients Regulation Overview for Ingredient Manufacturers
Singapore

This section provides the regulatory definition of the ingredients' categories in scope.

2.1 Pharmaceutical Product

Definitions

Therapeutic Product

Under the First Schedule of the Health Products Act 2007, a therapeutic product is any substance that:

1. is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes: 
   1. for preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or any symptom thereof;  
   2. for investigating, modifying, or replacing any physiological process; 
   3. for influencing, controlling or preventing conception; or 
   4. for inducing anaesthesia. 
2. has as its constituent any of the following active ingredients: 
   1. any chemical or botanical element, naturally occurring chemical or botanical material or chemical product obtained by chemical change or synthesis; 
   2. any metabolite from a micro-organism; 
   3. any macromolecule extracted from an organism; or 
   4. any substance derived from a biological system, including any of the following: 
      • a whole cell or micro-organism, such as a whole virus or bacterium used as a vaccine; 
      • a part of a micro-organism, such as a sub-unit vaccine; 
      • a plasma-derived product; or 
      • a biotechnology-derived substance, such as a protein or polypeptide; 
3. exerts an inherent effect either pharmacologically, chemically or by other physiological means, leading to its use for a therapeutic preventive, palliative or diagnostic purpose; and
4. is not any of the following: 
   1. a medical device; 
   2. any product containing human or animal cell or tissue;   
   3. any substance administered to humans with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; 
   4. whole blood or any blood component; 
   5. any Chinese proprietary medicine; 
   6. any homoeopathic medicine;  
   7. any medicated oil or balm;  
   8. any quasi-medicinal product; or 
   9. any traditional medicine.

Forensic Classification

Upon satisfying the regulatory requirements for quality, safety and efficacy, a therapeutic product may be registered under one of the following forensic classifications, which determines the level of control for access:

Prescription-Only Medicine (POM) if:

1. The product poses a direct or indirect danger to human health, even when used correctly, if used without medical supervision;
2. The product is frequently and widely used incorrectly and, as a result, is likely to present a direct or indirect danger to human health;
3. The product requires further investigation into its activity and/or side effects; and/or 
4. The product is normally prescribed by a doctor or dentist to be administered parenterally.  

Pharmacy-Only Medicine (P) is required for products that possess characteristics that are not sufficiently critical to warrant POM control but for which the following apply:

1. Consultation with a pharmacist is necessary to confirm the appropriate choice of therapy;
2. The contraindications, drug interactions, precautions or warnings need reinforcement by a pharmacist or are not easily recognized by the purchaser; or 
3. Special precaution is needed in the storage and handling of the product.

General Sales List Medicines (GSL) control is sufficient when:

1. The product is reasonably safe and can be sold or supplied without the need for supervision by a registered doctor, dentist or pharmacist;
2. The contraindications, drug interactions, precautions and warnings are easily recognized by the consumer; 
3. The hazard to health, the risk of misuse, the risk of misdiagnosis, or the need to take special precaution in the storage and handling the product is small.

2.2 Health Supplement

Definition

A health supplement is a product that is used to supplement a diet and to support or maintain, enhance, and improve the healthy functions of the human body. It cannot be an injectable or a preparation that needs to be sterile, such as injections and eyedrops. It cannot be an item of a meal or diet.

A health supplement must also contain one or more, or a combination of the following ingredients:

1. Vitamins, minerals, amino acid, fatty acids, enzymes, probiotics and other bioactive substances;
2. Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates; and
3. Synthetic sources of ingredients mentioned in (a) and (b).

A health supplement must be administered in small unit doses in dosage forms such as the following:

• Capsules
• Soft gels
• Tablets
• Liquids
• Syrups

2.3 References

1. Health Products Act 2007

https://sso.agc.gov.sg/Act/HPA2007

2. Health Products (Therapeutic Products) Regulations 2016

https://sso.agc.gov.sg/SL/HPA2007-S329-2016

3. Regulatory overview of health supplements

https://www.hsa.gov.sg/health-supplements/overview