Singapore: Health Sciences Authority provides update on electronic common technical document (eCTD) implementation

By neub9
4 Min Read

In Summary

The Therapeutic Products Branch of the Health Sciences Authority (HSA) in Singapore has provided an update on the progress of the implementation of eCTD following an industry consultation held between May 2, 2023, and June 12, 2023.

As previously mentioned in our May 2023 alert, the HSA plans to implement eCTD submissions in Singapore. eCTD is a standardized structured format for companies to transfer regulatory information related to therapeutic products to facilitate dossier submissions.

The implementation is planned to be in phases, and initially, the adoption by the industry will be on a voluntary basis during the rollout.

For further information on the background, you can access our previous alert here.

Updates After Industry Consultation

Following feedback from industry stakeholders, the HSA has provided an interim update on the key changes that are underway:

1. Issuance of unique e-identifier via the eCTD portal to be used as the applicable folder name.

Companies will no longer need to generate a universal unique identifier (UUID) and separately construct an application folder name with their PRISM application number. The issuance of the unique e-identifier, which serves as the applicable folder name, will help reduce the high likelihood of error that was present in the previous approach.

2. Updating of specification document to clarify the order of submission and including business workflow illustrations for baseline and transfer submissions.

These changes aim to remedy the lack of clarity on the submission procedures related to a company’s use of online portals and requirements for baseline submissions.

3. Introduction of the option to submit multiple dosage forms, presentations, or strengths as separate or single applications.

Further directions regarding the submission procedures and module organization for submitting multiple dosage forms or presentations in a single eCTD application will be provided.

4. Inclusion of regional stylesheet in the specification components package to facilitate viewing of envelope information.

This would serve to facilitate the viewing of envelope information.

5. Refinement of validation criteria to permit electronic signatures on PDF documents.

Prior to this change, electronic signatures were prohibited due to the security settings specified in the validation criteria.

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The HSA intends to incorporate the above changes and publish an updated eCTD specification package (version 1.0) in the second quarter of 2024.


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