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Health Sciences Authority
Regulatory Updates

POST-INDUSTRY CONSULTATION UPDATES ON ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) IMPLEMENTATION IN SINGAPORE

11 December 2023

Audiences

Industry member

Product-type

Therapeutic Products

The Therapeutic Products Branch (TPB) would like to provide an update on the progress of eCTD implementation following the industry consultation held from 2 May to 12 June 2023.

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

We would like to thank industry stakeholders for your participation and valuable feedback provided during the consultation exercise. We have received more than 250 comments from 25 companies. HSA is currently working with the vendor to address the feedback, and would like to provide an interim update on the key changes that are underway, summarised below:

Table caption

No.

Issue

Solution

1.

Need for companies to generate UUID and construct application folder name using PRISM application number which is prone to error


HSA will issue a unique e-identifier via the portal to be used as the application folder name.

Companies no longer need to generate UUID.

2.

Lack of clarity on the submission procedures:

a)Need for companies to use PRISM for application filing and eCTD portal for transmitting the dossier

b)Requirements for baseline submissions

HSA will update the specification document to clarify the order of submission in PRISM and eCTD portal.

HSA will include illustrations of business workflow for baseline and transfer submissions.

3.

Need for guidance on the procedures for submitting multiple dosage forms/presentations in one eCTD application


HSA will enable options for industry to include multiple dosage forms/presentations/strengths in a single application or submit as separate applications.

Guidance for industry on the submission procedures and module organisation to enable a single application will be provided in the updated package.

4.

Lack of SG regional stylesheet to facilitate viewing of envelope information

HSA will include a regional stylesheet in the specification components package.

5.

Electronic signatures on PDF documents are not allowed due to the security settings specified in validation criteria

HSA will fine-tune the validation criteria to allow electronic signatures in PDF documents.

An updated eCTD package version 1.0 will be published by Q2 2024. Industry stakeholders will receive an update on the following:

  • Summary of changes

  • Updated specification and validation criteria documents

  • Updated technical package (sample submissions, validation matrices, stylesheets)

  • Updated Q&A

  • Training and test submission schedules

Subscribe to the HSA announcements page here (opens in new tab) or visit the eCTD webpage to keep up to date with the latest eCTD developments.