Regulatory Updates
Regulatory Updates for Therapeutic Product Registration (effective 16 Jan 26)
16 January 2026
Audiences
Industry member
Product-type
Therapeutic Products
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As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in our regulatory requirements and processes, the Therapeutic Products Branch (TPB), Health Products Regulation Group, is pleased to update industry on the following:
1. Guidance updates with effect from 16 Jan 26
List of guidance updates
No. | Change | Description | The following guidance documents have been revised: |
1. | New submission pathway for standard essential medicines | This new submission pathway enables the registration of standard essential medicines through Generic Drug Applications (GDA). To qualify, a standard essential medicine must have a well-established efficacy and safety profile documented in recognised references. This pathway is designed for unregistered medicines that have a long history of local clinical use and are critical for Singapore's healthcare system, allowing them to leverage the established local clinical use as evidence for safety and efficacy. Products with a corresponding Singapore reference product are not eligible for this pathway. Before applying for product registration via this pathway, companies must assess the eligibility criteria and submit an Expression of Interest form via https://go.gov.sg/standard-essential-medicines (opens in new tab) at least 3 months before the planned GDA submission date. Companies may only proceed with their GDA submission after receiving the outcome of the EOI from HSA. |
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2 | Removal of limit of concurrent submissions for major variation applications (MAV-1) | The previous limit of three concurrent MAV-1 submissions in PRISM has been removed. This provides greater flexibility for industry stakeholders when submitting MAV-1 applications and enhances submission efficiency for post-approval extension of clinical indications. |
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3 | Good Manufacturing Practice (GMP) Conformity Assessment of overseas drug substance (DS) manufacturing sites | This new procedure allows companies to request HSA to conduct a GMP inspection for overseas DS manufacturing site where the site lacks the required evidence of GMP compliance at the point of submitting a registration application for a New Chemical / Biologic Entity (NCE / NBE). Companies must assess the eligibility criteria and submit an Expression of Interest form via https://go.gov.sg/ds-inspection (opens in new tab) at least 3 months before the planned NDA submission date. Companies may only proceed with their NDA submission after receiving the outcome of the EOI from HSA. |
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4 | Declaration of conflict of interest by company-engaged experts | For clarity and transparency, any statements of opinion by expert clinicians submitted by applicants to support an application must be accompanied by the expert clinicians’ written declaration confirming they have no conflict of interest in relation to the application. |
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These changes will take effect from 16 Jan 2026. Please refer to the updated guidance documents for detailed information.
2. eCTD test submission
The eCTD test submission phase was launched on 30 September 2025 and remains open until 27 March 2026. Feedback from companies that have submitted eCTD test packages has been valuable in refining processes to ensure smooth implementation.
We strongly encourage companies to submit test packages during this phase. This is an opportunity to familiarise yourselves with the eCTD system and submission process to ensure readiness for actual eCTD submission from 1 April 2026.
For full details on the test phase and guidance, please refer to our previous announcement.