In brief
On 16 January 2026, the Health Sciences Authority (HSA) implemented a series of updates on the registration of therapeutic products. The updates are aimed at further improving regulatory efficiency and enhancing clarity for applicants.
In more detail
On 16 January 2026, the HSA released the following key regulatory updates for the registration of therapeutic products:
1. New submission pathway for standard essential medicines
The new submission pathway allows standard essential medicines to be registered through generic drug applications (GDAs). To qualify for this submission pathway, the product must have a well-established safety and efficacy profile, and documented and recognised references. It must not have a corresponding Singapore reference product.
The submission pathway is designed for unregistered medicines that have a long history of local clinical use in Singapore and are critical for Singapore’s healthcare system.
Companies must submit an expression of interest (EOI) form at least three months prior to the intended GDA submission and may only proceed after receiving the HSA’s approval of their EOI.
2. Removal of the limit on concurrent MAV-1 submissions
The HSA has lifted the previous limit of three concurrent major variation applications (MAV-1). This enhancement provides industry stakeholders with greater flexibility in managing post-approval clinical indication expansions and reduces administrative hold-ups.
3. New GMP conformity assessment for overseas DS manufacturing sites
The HSA now permits companies to request that HSA conduct a good manufacturing practice (GMP) inspection for overseas drug substance (DS) manufacturing sites that lack sufficient evidence of GMP compliance when submitting a New Chemical / Biologic Entity (NCE/NBE) registration application.
4. Declaration of conflicts of interest by company-engaged experts
The HSA now requires that any statement of opinion provided by an expert clinician and submitted to support an application be accompanied by a written declaration from the expert clinician confirming that they have no conflict of interest in relation to the application.
Key takeaways
The HSA continues to refine its regulatory processes to ensure that they remain efficient, transparent and aligned with industry needs. These updates will be highly relevant to companies making or planning to make therapeutic product applications in Singapore.