On May 28, 2025, the Health Sciences Authority (HSA) of Singapore conducted an online training session on the eCTD portal, aiming to communicate the core functions and operational specifications of the eCTD portal to the industry. The training detailed the end-to-end processes from Corppass registration to eCTD ID application and eCTD package submission, confirming that eCTD, as the standard format for electronic submission of drug registration dossiers, will open a test submission phase in Q3-Q4 2025 and formally accept electronic submissions for new drugs, generic drugs, and Drug Master Files (DMFs) in Q2 2026.
1. eCTD and Non-eCTD Submissions in Singapore
eCTD Format: Submitted to PRISM, accepting only ZIP packages in ICH CTD format, uploaded via the eCTD portal.
Non-eCTD Format: Submitted to PRISM, supporting ICH CTD or ASEAN CTD formats. Non-eCTD submissions can be uploaded via CD/DVD, EasiShare, or PRISM.
2. eCTD Submission Process
Registration Submission: Prepare materials per Singapore requirements → Obtain an eCTD ID from the portal → Submit the application via PRISM and obtain an application number → Indicate the eCTD ID and PRISM application number in the package → Upload via the portal.
DMF Submission: Similar process, but obtain a DMF number from HSA instead of applying via PRISM.
3. Overview of Corppass System
System Positioning: A government-level entity authorization system for managing employees’ digital service access on behalf of the entity, distinct from the personal identity system SingPass, and managed by the government rather than HSA.
Registration Requirements:
Singapore Entities: Prepare business registration documents and identity documents, assign roles, and submit registration.
Foreign Entities: Can authorize third-party service providers to act on their behalf, requiring registration via SingPass Foreign User Account (SFA). The process is as follows: Register information with an SFA organization → After verification, the SFA organization pre-registers the account → SingPass issues the user ID via email, which is activated per instructions.
4. eCTD Portal Operation Demonstration
Core Functions of the Portal: Transmit eCTD sequences to HSA, supporting multiple users simultaneously (each user can submit only one package per session, which cannot be canceled or recalled after submission).
Usage Requirements: Internet access, Corppass account, eCTD ID, and a ZIP-format package.
5. eCTD ID Application Process
Log in to the portal.
Enter the "SG eCTD IDs" module → Click "Generate".
The system automatically generates a unique identifier in the format eYYYYMMDDsgXXXX (e.g., e20250514sg7432).
eCTD ID Attributes: Bound to the enterprise’s Corppass, associated with a specific application for life, can be disabled by HSA, and cannot be modified or transferred independently.
6. Preparation of eCTD Packages
Structural Requirements: A single eCTD sequence folder nested under the application folder, compressed into a ZIP format (file names do not affect review, but it is recommended to include the eCTD ID and sequence number, e.g., e20250514sg7430-0001.zip).
Size Limit: Maximum 50GB per ZIP package; contact HSA for 协商 (consultation) if exceeding the limit.
7. eCTD Submission Process
Upload Package: Drag and drop the ZIP file, and the system automatically scans for malware.
Compliance Check: Verify the validity of the eCTD ID and file structure.
Confirm Submission: Click "Submit" after passing the check, generating a transmission receipt (including Transmission ID and package details).
Validation Result: Notification via email within 24 hours, accompanied by a technical validation report (if failed).
8. Future Plans
Timing: Launches in Q3-Q4 2025, lasting 6 months.
Requirements: Prepare test packages per SG-eCTD Specification v1.0; test data will not be reviewed and will be deleted after the phase.
Accept eCTD materials for new drugs, generic drugs, and DMFs starting from Q2 2026.
Existing registered products can convert to eCTD format via baseline submission, accompanied by a declaration confirming consistency with existing registered dossiers.
9. Selected Q&A Sessions
Q: Is Corppass still required if I have a SingPass?
A: Corppass is required because the former is for personal identity, while the latter authorizes employees to conduct government affairs on behalf of the enterprise.
Q: Is Corppass registration fee-based?
A: No, it is free, same as SingPass.
Q: How to handle failed package validation?
A: The portal will display an error code (e.g., 2001 indicates an application folder structure error). Refer to the online manual for corrections and resubmit.
Q: Can multiple users use the same eCTD ID simultaneously?
A: Yes, supporting different users to submit various regulatory activities (e.g., variation applications, supplementary materials) under the same ID.
Q: Is eCTD software mandatory?
A: No, materials can be prepared independently or entrusted to third parties. Validation tools can be obtained from service providers or used for free (compatibility testing required).
Q: Can the eCTD ID be customized?
A: No, the original format generated by the portal must be used; otherwise, validation will fail.
In the context of HSA accelerating the eCTD electronic submission trend, Beijing BrilliantMed Pharma Tech Co., Ltd., as a professional service provider deepening in pharmaceutical regulatory compliance, has comprehensively laid out support systems for eCTD portal applications. Based on the core points of this HSA eCTD portal training meeting, we understand the pain points of enterprises in key links such as Corppass registration, eCTD ID generation, and package compliance preparation. Relying on our senior regulatory strategy team and technical tools, we provide end-to-end empowerment from account setup, document compilation to test submission, helping enterprises seamlessly connect with HSA’s Q3-Q4 2025 test submission cycle and Q2 2026 official application node.
