1. Overview

Registration process

Who can register

You will need to be a local company registered with the Accounting and Corporate Regulatory Authority (ACRA) in order to proceed with a therapeutic product registration.

Pre-submission preparation

The following are important considerations before you register your therapeutic product.

Note: Different formulations, dosage forms, presentations and strengths of the same chemical or biologic entity are considered different products, and will require separate registrations.

Product types

Therapeutic products could contain either chemical or biological entities as the active ingredients.

A chemical entity refers to any chemical element, naturally occurring chemical material or chemical product obtained by chemical change or synthesis. This includes macromolecules produced by chemical synthesis, such as peptides and oligonucleotides, or any metabolites from a micro-organism, such as antibiotics.

A biological entity refers to any macromolecule extracted from an organism, such as proteins, nucleic acids, proteoglycans, cytokines and growth factors. It can also refer to any substance derived from a biological system, including:

• 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.

• A biotechnology-derived substance, such as a protein or polypeptide.

Forensic classifications

You may register your therapeutic product under the following forensic classifications, which determine the level of access control:

• Prescription-Only Medicines (POM): A therapeutic product that can only be obtained from a doctor or from a pharmacist with a valid prescription.

• Pharmacy Only Medicines (P): A therapeutic product that can be obtained from a pharmacist at a retail pharmacy without a prescription.

• General Sale List (GSL): A therapeutic product that can be obtained from any retailer.  

Refer to section 1.2 of the Guidance on Therapeutic Drug Registration for more information.

Patent declaration

Under regulation 23 of the Health Products (Therapeutic Products) Regulations (“Regulations”), an applicant seeking to register a therapeutic product is required to make a declaration on whether the therapeutic product is subject to a subsisting restraining patent.

For applicants of product registration, the relevant resources are provided below:

• The form for furnishing a declaration under regulation 23(2) of the Regulations is specified in Appendix 1-Patent Declaration Form 1  of the Guidance on Therapeutic Product Registration in Singapore.

• The form for serving a notice on the proprietor of a restraining patent under regulation 23(5) of the Regulations is specified in Appendix 1-Form 2  of the Guidance document.

 For proprietors of a restraining patent, the relevant resources are provided below:

• The form for furnishing a declaration under regulation 23(8)(b)(iii) of the Regulations is specified in Appendix 1-Form 3 of the Guidance document.

• The online Submission of Written Notice by Proprietor of Restraining Patent on Application for a Court Order / Declaration form to submit the written notice, evidence, and declaration.

For more information on the patent declaration procedure, please refer to Chapter A, Section 3 of the Guidance document.

Overseas manufacturers of therapeutic products

All new overseas manufacturers who intend to register therapeutic products in Singapore after 1 April 2004 will be subjected to a Good Manufacturing Practice (GMP) conformity assessment by us.

How to apply

Submit your application through PRISM. Ensure you have the following before you access the e-service:

• CRIS company account

• Corppass or HSA PIN

If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).

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Application types