The Health Sciences Authority (HSA) of Singapore has officially enforced the SGeCTD v1.1 submission standard as of April 1, 2026. All drug registration dossiers submitted via eCTD must use version 1.1, and the previous version 1.0 has been discontinued.
For pharmaceutical companies expanding into Southeast Asia and targeting the Singapore market, this is a mandatory compliance milestone. Beijing BrilliantMed Pharma Tech Co., Ltd., a professional team specializing in global eCTD publishing, has actively taken part in the testing of Singapore HAS eCTD portal. We now compile the scope of application, key updates, and major changes from v1.0 to v1.1 of Singapore eCTD for you.
I. Scope of eCTD
Currently, Singapore eCTD is voluntary, however HAS strongly recommend, with priority coverage for:
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Drug Master File (DMF) submission
Baseline conversion for marketed products
Lifecycle submissions including variations, renewals, PSURs, etc.
Once eCTD is adopted, all subsequent submissions for the same product must continue with eCTD format.
II. Comprehensive Technical Package Updates
SGHSA eCTD Specification v1.1
SGHSA eCTD Validation Criteria v1.1
Redefined lists for application type, submission type, sequence type, etc.
Synchronized upgrade of the eCTD document matrix
III. Core Upgrades comparing v1.1 & v1.0
Items | V1.0 | V1.1 |
Technical Requirement Changes |
eCTD Document Matrix | Mandatory submissions: 1. DMF Acknowledgement Email (1.5.1) 2. Application Form (1.2.1) | The above two submission requirements are removed |
Granular Attachments | Application Checklist (1.2.2) limited to a single file | Application Checklist supports multiple files |
Validation Standard Changes |
Initial Submission Sequence Type (2.1.9) | No validation requirement | Initial submission sequence must be set to Initial |
Clinical Study Expansion Nodes (3.4.8) | Clinical studies only allow expansion nodes | Clinical studies for 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5 and 5.3.7 must use STF or expansion nodes |
Source File Check (4.6) | 1.2.2, 1.3.3.2, 1.3.3.3, 1.3.4.2, 1.3.4.3, 1.8.3.1 and 1.8.3.2 must submit .doc/.docx source files; validation level: Warning | Remove the requirement for 1.2.2; downgrade validation level of other source file checks to Informational; remove operation requirements for subsequent sequences |
Envelope Information – DMF Acknowledgement Email (4.7) | If 1.5.1 “DMF Acknowledgement Email” is submitted, dmf-number must be filled | Remove relevant instructions |
Specifications and Processes |
Warning Handling | No mandatory explanation requirement | Warnings in Section 3 or 4 must be justified in the cover letter; excessive/repeated warnings may result in rejection |
Word Source Files | Mandatory submission | Changed to optional |
Withdrawal/Rejection procedures | Not specified | A withdrawal sequence must be submitted to revert to an earlier version |
Singapore eCTD v1.1 marks a key step in digital drug submissions in Southeast Asia. With strict standards and clear processes, it presents both compliance requirements and opportunities for efficiency improvement for Chinese pharmaceutical companies going global. Early preparation, ready-to-use templates, and thorough validation will help you seize the opportunities in the Singapore market steadily.
With years of experience in international eCTD submissions, Beijing BrilliantMed Pharma Tech Co., Ltd. keeps up with the latest HSA Singapore regulations and accurately addresses key changes in v1.1 regarding sequence types, operational attributes, validation warnings, source files, etc. We provide one-stop Singapore eCTD services from baseline conversion, dossier building, format validation to submission and acceptance, supporting Chinese and foreign pharmaceutical companies to enter the Singapore market efficiently and compliantly.
