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