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Singapore's HSA: Regulatory Updates for Therapeutic Product Registration

On 30th June 2023, Singapore's Health Sciences Authority (HSA) released updated guidance on "Regulatory Updates for Therapeutic Product Registration" which outlines the regulatory processes and requirements for therapeutic product registration.

The purpose of this guidance is to provide guidance on the procedures and requirements for submitting an application to register a therapeutic product or to apply for a variation to an existing therapeutic product, to the HSA.

A therapeutic product registered under the HPA is specific to the product with respect to its:

  • proprietary or brand name;

  • pharmaceutical formulation;

  • pharmaceutical dosage form (i.e. physical presentation) and strength; and

  • indication(s) and dosing regimen.

Application and all supporting documents are to be submitted by the applicant (including but not limited to documents related to the dossier, responses to HSA's questions, and letters of commitment).

Therapeutic products should be registered taking into account the following factors:

(a) Knowing which type of application to apply for;

(b) Knowing which evaluation route to choose; and

(c) Understanding the requirements as specific in this guidance.

There are four types of evaluation routes for registering a new therapeutic product, a Full route, an Abridged route, a Verification route & Verification-CECA route. The submission of an application comprises two key steps one is the online submission of the application form via PRISM and the second submission of the technical dossier.

Based on the data submitted in support of the application, HSA makes a regulatory decision following the conclusion of its benefit-risk assessment.

Click this LINK to know more details about the requirements for Therapeutic Product Registration.


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