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This application is a service of the Singapore Government.

Health Sciences Authority

Therapeutic Product Registration

All therapeutic products are required to be registered with the Health Sciences Authority before they can be supplied in Singapore.

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

(a) is intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose, including any of the following purposes:

(i) for preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or any symptom thereof;

(ii) for investigating, modifying, or replacing any physiological process;

(iii) for influencing, controlling or preventing conception; or

(iv) for inducing anaesthesia.

(b) has as its constituent any of the following active ingredients:

(i) any chemical or botanical element, naturally occurring chemical or botanical material or chemical product obtained by chemical change or synthesis;

(ii) any metabolite from a micro-organism;

(iii) any macromolecule extracted from an organism; or

(iv) any substance derived from a biological system, including any of the following:

(A) a whole cell or micro-organism, such as a whole virus or bacterium used as a vaccine;

(B) a part of a micro-organism, such as a sub-unit vaccine;

(C) a plasma-derived product; or

(D) a biotechnology-derived substance, such as a protein or polypeptide;

(c) 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

(d) is not any of the following:

(i) a medical device;

(ii) any product containing human or animal cell or tissue;

(iii) any substance administered to humans with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;

(iv) whole blood or any blood component;

(v) any Chinese proprietary medicine;

(vi) any homoeopathic medicine;

(vii) any medicated oil or balm;

(viii) any quasi-medicinal product; or

(ix) any traditional medicine.

A company seeking to market a therapeutic product can make an application for registration via PRISM.

There are two categories of registration applications for therapeutic products – new drug application (NDA) and generic drug application (GDA).

Any post-registration changes that occur during the product’s life cycle that may affect the product’s efficacy, quality and/or safety can only be made after approval for the variation has been obtained from HSA. There are two types of variation applications – major variation applications (MAV) and minor variation applications (MIV).

Please refer to the Guidance on Therapeutic Product Registration for more information on application types.

Please refer to the following for more information on product registration/consignment approvals:

 

I need information on..

 

Reference

 

Registering a Therapeutic Product

 

Click here for Guidance

 

Application fees

 

Click here for fees

 

Application processing timelines

 

Click here for Target Processing Timelines

Submitting my application online

 

Click here for CRIS application

Click here for PRISM submission guide (Appendix 17)

Click here for PRISM e-Services page

 

Consignment Approval for Unregistered Product for Patients’ Use

 

Click here for Guidance.

Import and Supply of Registered Therapeutic Product on Consignment Basis

Click here for Guidance.