The Health Sciences Authority (HSA) of Singapore released regulatory updates at the end of September 2024. The updates involve the implementation of the digital portal SHARE and Specific Package (v1.0) for Electronic Common Technical Document (eCTD) in Singapore.
SHARE Portal for Class 2 CTGTP Registration
As published by HSA on 18 September 2024, the new digital portal – Singapore Health Product Access and Regulatory E-System (SHARE) will be launched on 7 October 2024 for registration Class 2 Cell, Tissue, and Gene Therapy Products (CTGTP).
Any FormSG submission for CTGTP registration or variation applications received by the cutoff date of 30 September 2024 will be processed as usual. Applications submitted after this date must be submitted via the SHARE platform starting from 7 October 2024. A friendly reminder to all industry stakeholders: there are no changes to regulatory or submission requirements with this platform transition.
SG-HAS eCTD Specification Package (v1.0)
The Therapeutic Product Branch of HSA released the SG-HAS Specification version 1.0 to help industry stakeholders prepare for the testing and implementation of eCTD submissions, with the system expected to roll out in March 2025. The package contains the following documents:
SG-HAS eCTD Specification and Validation criteria
Technical files
Sample eCTD submissions
Some summary changes in the latest specification package are:
A unique e-identifier (SG eCTD ID) can be obtained by submitting a request via the eCTD portal for an eCTD application. This ID will be used as the application folder name and will apply to all sequences of the eCTD application throughout the product's entire lifecycle.
Companies submitting a baseline for currently registered products in a non-eCTD format are only required to submit a Cover Letter, excluding Module 3 CMC data. If previously submitted and approved content is included in the baseline submission, the Cover Letter must include a declaration stating that there have been no changes to the content currently registered with HAS
HSA will allow the industry the option to include multiple dosage forms, presentations, or strengths in a single application, or to submit them as separate applications. Applicants should carefully consider the advantages and disadvantages of combining or separating strengths, based on the product's life cycle management.
The system is expected to open for the test submission phase from March – September 2025 (6 months). HSA will also provide online training around February 2025.
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