The Implementation of eCTD in Singapore

As it prepares for its implementation in the fourth quarter of 2024, Turlough McKenna examines the process and its implications for Singapore.

With a consultation period running from May 2, 2023, to June 12, 2023, a supporting package was published on the SG-HAS website upon launch.

This provided stakeholders with relevant information, including the Singapore Regional Specification v0.9, Module 1 Envelope Attributes and Defined Lists, Heading Elements, and eCTD Validation Criteria v0.9.

Additionally, a virtual Industry Briefing Session was hosted by SG-HAS on May 9, 2023. The release of version 1 (V1) SG-HSA eCTD Specifications, along with a summary of changes, is expected by Q2 of 2024. SG-HSA is set to commence accepting test submissions in the fourth quarter of 2024.

The implementation of the eCTD format will be conducted in phases.

These will start with new NDAs (New drug applications), GDAs (Generic drug applications), DMFs (Drug Master Files), and their subsequent post-approval changes.

Initially, industry adoption of eCTD for these submission types will be voluntary. There is no specified timeline for transitioning currently approved products to eCTD. However, the SG-HSA has stated that advance notice will be given to existing dossier holders for future phases.

Companies equipped with eCTD capabilities are encouraged to submit relevant applications in eCTD format at the earliest opportunity. SG-HSA advises dossier holders who are interested in switching to eCTD submissions for already registered therapeutic products to contact them for guidance.

It is important to note that once an application has been submitted in eCTD format, it cannot be reverted to another format. All subsequent lifecycle management activities must adhere to SG-HSA guidance on eCTD. With the release of the SG-HSA eCTD Specification V1, additional guidance will be provided regarding specific differences proposed by SG-HSA.

These include the allowance of Word documents in Module 1 and the acceptance of comma-separated value (CSV) and plain text (TXT) files in Modules 4 and 5. The initial implementation of the eCTD will use version 3.2.2, with SG-HSA planning to migrate to eCTD specification version 4.0 in the future.

Modules 1-5 of the application must be in eCTD format, and all submissions should be validated according to the ICH CTD structure before submission.

One year after the initial launch of eCTD, an updated SG-HSA eCTD Regional Specification is expected to be released. This update will be informed by the experiences gained during the initial phase.

An issue raised by the industry during the consultation period was the inability to use electronic signatures on PDF documents under the current version of the SG-HSA validation criteria, due to specified security settings.

Responding to this concern, the HSA confirmed on December 11, 2023 that the validation criteria would be fine-tuned before the launch to permit electronic signatures in PDF documents.

To submit eCTD applications, applicants are required to use the eCTD portal eService via CorpPass. Users of these e-services will need SingPass.

The portal specifies that all packages must be in a ZIP file without encryption or password protection, with a package limit of 50GB.

Upon successful transmission, a receipt will be displayed on the screen, which can be saved for records in either PDF or XML format.

References:

• eCTD Industry Briefing Session, Health Science Authority, 2023
• Industry briefing slides, Health Science Authority, 2023
  
• INDUSTRY CONSULTATION ON ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) IMPLEMENTATION IN SINGAPORE, Health Science Authority, 2023
• Post-industry consultation updates on Electronic common technical document (eCTD) implementation in Singapore, Health Science Authority, 2023
• SG-HSA eCTD Question and Answers Document, Health Science Authority, 2023
• SG-HSA eCTD Specification and Guidance for Use V0.9, Health Science Authority, 2023
• SG-HSA eCTD Validation Criteria v0.9, Health Science Authority, 2023