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Health Sciences Authority

Tools and resources

View the list of tools and resources for therapeutic product registration

Last updated 7 May 2026

Self-help tools

  1. Registration Application Timeline Calculator

Estimate the key milestone timelines of your therapeutic product registration and major variation applications.

  1. MIV tool

Determine which MIV (Minor Variation) category your change falls under and what submission requirements apply.

Other resources

Common Questions related to generic drug applications

Questions and answers relating to bioequivalence (BE) study requirements and Singapore Reference Product (SRP)

Common questions related to Biosimilars

Questions and answers relating to biosimilar registration in Singapore.

Listing of approvals and post-registration actions

View the list of approvals and post-registration actions for registered products.

Summary of Benefit-risk Assessment Reports

The reports contain a summary of the quality, safety and efficacy of approved new chemicals and biologics, and HSA's benefit-risk assessment for the approvals.

Useful links