Regulatory Updates for Therapeutic Product Registration (effective 16 Jan 26)

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 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.

• Main guide: Section 16.2 Standard Essential Medicines
  
  

• Application checklists for GDA (Appendices 2A, 3A)

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.

• Main guide: Section 24 MAV-1 applications

• Appendix 17 Guideline on PRISM submission

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 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.

• Main guide sections 15.1 and 18.1

• Application checklists for NDA (Appendices 2A, 3A)

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.

• Main guide 6.2.1 Submission requirements