Therapeutic Product Registration

Find out how to register your therapeutic product and manage the product registration here.

Registration overview Understand the therapeutic product registration process before you register your product. 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. eCTD submissions for Therapeutic Products Submit documents in a standardised electronic format for therapeutic product registration. Summary Reports of Benefit-Risk Assessment Provides information about the evaluation of New Drug Applications (NDA-1) and shares the considerations behind the approval of the therapeutic product.  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 GMP conformity assessment of overseas drug product (DP) manufacturers Overseas manufacturers who intend to register therapeutic products in Singapore may be subjected to a Good Manufacturing Practice (GMP) conformity assessment by HSA. Lot release for imported vaccines Submit a notification to us on the lot release information of imported registered vaccines before you supply them in Singapore. 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. 

 RMP submission for product registration Find out when a risk management plan (RMP) submission is required and the documents to be submitted. ​Special Access Routes (SAR) In specific situations, we may allow the import or the supply of therapeutic products via Special Access Routes (SAR).