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This application is a service of the Singapore Government.

Frequently Asked Questions

Health Products Regulation

Therapeutic Products > Therapeutic Product Registration > Registering a new Therapeutic Product (TP)

1.
How do I know if my product is a Therapeutic Product?

Therapeutic Products generally refer to products that contain one or more chemical or biologic active ingredient(s) which are intended for use by and in humans for a therapeutic, preventive, palliative or diagnostic purpose. Please click here for the definition of a Therapeutic Product.

You may also fill in the Health Product Enquiry form and email it to HSA_Prod_Class@hsa.gov.sg if you need further advice.

2.
How do I register a Therapeutic Product?

Please refer to of the Guidance on Therapeutic Product Registration in Singapore (2016) for the requirements for therapeutic product registration.

A company that is registering a therapeutic product, i.e. the applicant, must be a local business entity registered with the Accounting and Corporate Regulatory Authority (ACRA) in Singapore. Applications must be submitted online via PRISM and the applicant is required to obtain a HSA CRIS account in order to make the submission. Guidance on the submission via PRISM is available here

The person acting on behalf of the company in submitting the application must be duly authorized by the company CRIS administrator.  Information on CRIS can be found here.  

For application fees, please click here.  For target processing timelines of applications, please click here.

3.
How do I arrange for a pre-submission meeting?

An applicant may request for a pre-submission meeting if there are specific scientific issues concerning the technical dossier that require clarification, prior to the submission of application.  Any meeting request must be accompanied by a proposed meeting agenda and pre-read materials pertinent to the issues to be discussed. To make a pre-submission meeting request, please email: HSA_TP_Enquiry@hsa.gov.sg

4.
How do I request for priority review for new drug applications? Is there a reduced timeline for such applications?

An applicant may request for priority review for a new drug application (NDA)if the drug is intended for treatment of a serious life-threatening condition and has demonstrated the potential to address local unmet medical needs. Any request for priority review must be accompanied by relevant scientific justification substantiating the basis of the ability of the new drug to address a local unmet medical need. For details of the qualifying criteria for priority review and the necessary justification, please refer to the Guidance on Therapeutic Product Registration in Singapore 2016.

The timeline for an application accorded with priority review will generally be shorter than standard abridged applications i.e. less than 180 working days excluding stop-clock.

The applicant will be able to monitor the progress of evaluation through PRISM (e.g. active evaluation, mid-way stage, evaluation complete). 


5.
Do I need to submit product samples for registration?

Product samples are not required for registration. 

6.
What are biosimilar medicines?

Biosimilars are “follow-on” versions of innovator biologic medicines. These “follow-on” versions are required to demonstrate similarity in physical and chemical characteristics, biological activity, safety and efficacy to the first approved biologic medicine, also referred to as the reference biologic product (RBP).  The route of administration, dosage form and the strength of the biosimilar product should be same as the RBP. Biosimilar product is not identical but similar to the RBP.

7.
How are biosimilar products approved?

Biosimilar products are required to go through a scientifically rigorous pathway based on a stepwise head to head comparability to the RBP in terms of quality of product (physical and chemical characteristics), non-clinical studies (toxicity, functionality) and clinical studies (safety, efficacy & immunogenicity). The comparability is designed to show similarity and demonstrate that there are no clinically meaningful differences between the RBP and biosimilar product.  

FAQs