Regulatory overview of therapeutic products

What is a therapeutic product?

Therapeutic products, commonly known as pharmaceuticals, are health products intended for use in humans for a therapeutic, preventive, palliative or diagnostic purpose. Therapeutic products can contain chemical or biologic substances as active ingredients, which exert their effect either pharmacologically, chemically or by other physiological means.

The following products are not considered therapeutic products:

• Topical antiseptics 

• Chinese proprietary medicines

• Traditional medicines

• Homoeopathic medicines

• Health supplements 

• Medicated oil and balms

• Medical devices

• Mosquito repellents (refer to the National Environmental Agency for more information)

Legislation

We regulate therapeutic products in Singapore under the Health Products Act (HPA) and its regulations, including the Health Products (Therapeutic Products) Regulations 2016.

Scope of regulation

We require companies to obtain a dealer's licence before manufacturing, importing or supplying therapeutic products. All therapeutic products will require registration with us before they can be supplied in Singapore.

Clinical trials

You may be required to apply for a Clinical Trial Authorisation or submit a Clinical Trial Notification before conducting clinical trials of therapeutic products in Singapore.

Therapeutic product registration

You must register your therapeutic product before you can supply it in Singapore. Registration requirements will differ depending on whether you submit a new drug application or generic drug application, and also on your chosen registration evaluation route.

Dealer's licensing

You will need to apply for a dealer's licence before you can import, manufacture and supply your therapeutic products in Singapore. We will assess if you meet Good Distribution Practice and Good Manufacturing Practice requirements before issuing your licence.

Variation application

Submit a variation application to us when there is a change to your registered therapeutic product's safety, efficacy, quality or forensic classification.

Advertisement and sales promotion

You do not need to obtain prior approval from us before you advertise or promote your therapeutic product. However, you must comply with our regulations regarding advertising claims of your therapeutic product. Advertising and promotional messages should not contain misleading claims, lead to improper use of the product, or bring undue harm to the public.

Adverse events reporting

If the therapeutic product you are marketing poses a serious threat to health, causes death, or undesirable effects, you must report the adverse event to us within a given time frame.

Product defect reporting

As a dealer or product registrant, you are responsible for the safety, quality and efficacy of your therapeutic products, and must know how to report and recall defective products that may potentially cause harm to patients or the public.