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Health Sciences Authority
Regulatory Updates

INDUSTRY CONSULTATION ON ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) IMPLEMENTATION IN SINGAPORE(2 MAY - 12 JUNE 2023)

13 June 2023

Audiences

Industry member

Product-type

Therapeutic Products

The Therapeutic Products Branch (TPB) is pleased to invite industry to participate in the consultation on eCTD submissions for therapeutic products held from 2 May 2023 to 12 June 2023.

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

(*Updated 12 June 23:  Industry consultation is now closed)

The purpose of the consultation is to provide an opportunity for industry to comment and feedback on the eCTD specification package. Your feedback is important for us to understand the potential impact on industry stakeholders and to ensure a smooth implementation of eCTD in Singapore.

The documents are listed below and may be downloaded here

1) Specification Components   

  •  SG-HSA eCTD Regional Specification Document* version 0.9 including:

  • Regional SG-HSA Module 1 Schema  and supporting Schemas  

  • SG-HSA eCTD Sample Submissions 

*The SG-HSA eCTD specification 0.9 initial release is for industry feedback only and will not be used for eCTD applications. This will be updated to version 1.0 based on the consolidated feedback, which will be the official specification used for the first eCTD submissions.

2)  Validation Components

  • SG-HSA eCTD Validation Criteria including SG-HSA Granularity Annex

  • SG-HSA eCTD Document Matrix 

  • SG-HSA eCTD Submission Type Matrix 

  • Defined Lists 

3)  Q&A document

  • SG-HSA eCTD Questions and Answers 

Industry Briefing Session

As part of the consultation, we will also be holding an Industry Briefing Session on 9 May 2023. Industry stakeholders and eCTD software vendors are invited to attend.  (*Updated 5 May 23: Registration is now closed)

Event: Industry briefing session on eCTD implementation in Singapore

Agenda:

1. Introduction

2. An overview of eCTD implementation in Singapore (Preparation, validation, and submission through eCTD portal)

3. Consultation details

4. Questions and answers

Date: 9 May 2023 (Tuesday)

Time: 2.00 - 4.30 pm

Venue: Online webinar via Zoom (Webinar link will be sent to participants by 5 May 2023)

Post-consultation Follow-up

The following documents will be made available on the HSA website (Q1 2024) after the consultation:

1) SG-HSA eCTD Regional Specification Document version 1.0, to be used for eCTD submissions once implemented.

2) Summary of changes taking into consideration the feedback received during the consultation.

The target implementation of eCTD in Singapore is Q4 2024. We will keep the industry informed of any updates.

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.