In brief
The Therapeutic Products Branch of the Health Sciences Authority (HSA) has provided an interim update on the progress of the eCTD implementation in Singapore following an industry consultation held between 2 May 2023 to 12 June 2023.
Background
As updated in our previous alert of May 2023, the HSA intends to implement eCTD submissions in Singapore. eCTD is a standard structured format for companies to transfer regulatory information related to therapeutic products to facilitate dossier submissions.
The implementation was envisaged to take place in phases and adoption by the industry will be on a voluntary basis during the initial roll-out.
Further details on the background may be accessed in our previous alert here.
Post-industry consultation updates
Following the feedback provided by 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 seek to remedy the lack of clarity on the submission procedures relating to a company’s use of online portals and requirements for baseline submissions.
3. Introduction of option to submit multiple dosage forms, presentations or strengths as separate or single applications.
Further directions relating to 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 envelop information.
This would serve to facilitate the viewing of the 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) by the second quarter of 2024.
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