Registration overview
Find out how to register your therapeutic product and manage the product registration here
Last updated 12 May 2026
Registration process for therapeutic products
Understand the therapeutic product registration process before you register your product.
Pre-submission Consultation Mechanisms
The range of mechanisms that enable companies to self-help include the use of guidelines, flow charts, frequently asked questions (FAQ) and self-help tools as alternatives to pre-submission meeting.
eCTD submissions
Submit documents in a standardised electronic format for therapeutic product registration.
Good Manufacturing Practice (GMP) conformity assessment of overseas manufacturers of therapeutic products
Overseas manufacturers who intend to register therapeutic products in Singapore may be subjected to a Good Manufacturing Practice (GMP) conformity assessment by HSA.
Good Manufacturing Practice (GMP) evidence for overseas Drug Substance (DS) manufacturers
Overseas drug substance manufacturers will need to provide evidence of GMP compliance to support product registrations or variations in Singapore.
Notification of lot release information of imported vaccines for local supply
Submit a notification to us on the lot release information of imported registered vaccines before you supply them in Singapore.
Submission of Drug Master File
Follow this guide to find out the processes for the submission and processing of a Drug Master File for a therapeutic product registration.
Submission of Plasma Master File
Follow this guide to find out the processes for the submission and processing of a Plasma Master File for a therapeutic product application.