Changeflow GovPing Healthcare & Life Sciences HSA Singapore SG-eCTD Version 1.1 Package Update
Routine Notice Amended Final

HSA Singapore SG-eCTD Version 1.1 Package Update

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Summary

The Health Sciences Authority (HSA) of Singapore has released an updated package for SG-eCTD version 1.1. This update pertains to the electronic Common Technical Document submission format used for regulatory filings.

Published by HSA on hsa.gov.sg . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

The Health Sciences Authority (HSA) of Singapore has announced the release of an updated package for SG-eCTD version 1.1. This update concerns the electronic Common Technical Document (eCTD) submission format, which is utilized for regulatory applications related to pharmaceuticals and medical devices.

While this is an update to a technical submission format, regulated entities such as drug manufacturers and medical device makers should ensure they are using the latest version of the SG-eCTD package to maintain compliance with HSA's submission requirements. Specific details regarding the changes within version 1.1 and any associated implementation guidance should be reviewed on the HSA website.

What to do next

  1. Review the updated SG-eCTD version 1.1 package released by HSA Singapore.
  2. Ensure current submission processes align with the updated SG-eCTD specifications.

Archived snapshot

Mar 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Last updated

Classification

Agency
HSA
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Drug manufacturers Medical device makers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing 3345 Medical Device Manufacturing
Activity scope
Regulatory Submissions
Geographic scope
Singapore SG

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11
Topics
Pharmaceuticals Medical Devices

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