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Singapore's HSA: Post-Industry Consultation Updates on eCTD Implementation in Singapore

On 11th December 2023, Singapore's Health Sciences Authority (HSA) released an update "Post-Industry Consultation Updates on Electronic Common Technical Document (eCTD) Implementation in Singapore" which outlines the key updates and insights into the progress and expectations surrounding eCTD implementation.

Based on the industry consultation held from 2 May to 12 June 2023, the Therapeutic Products Branch (TPB) would like to update you on the status of eCTD implementation. The adoption of eCTD is a pivotal step toward modernizing regulatory submissions, and aligning Singapore with global standards and best practices.

The recent post-industry consultation updates on the implementation of the Electronic Common Technical Document (eCTD) underscore the nation's commitment to streamlining processes and embracing digital transformation within the pharmaceutical and healthcare sectors.

This document summarizes the key changes underway as a result of the feedback received by Therapeutic Products Branch (TPB) from 25 companies. HSA is currently working with the vendor to address the feedback, and has provided an interim update on the key changes that are underway.

The updated eCTD package version 1.0 is scheduled for publication by Q2 2024 and will provide industry stakeholders updates 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

HSA will adopt a phased approach for eCTD implementation for therapeutic product submissions based on ICH eCTD specification 3.2.2.


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