Regulatory overview of therapeutic products

Understand the scope of regulations on therapeutic products in Singapore.

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.

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
Therapeutic product registration
Dealer's licensing
Variation application
Advertisement and sales promotion
Adverse Events reporting
Product defect reporting
Import, manufacture of therapeutic products

Clinical trials

You must first apply for a Clinical Trial Authorisation (CTA) or submit a Clinical Trial Notification (CTN) before conducting clinical trials of therapeutic products in Singapore.

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