The Singapore Health Sciences Authority (HSA) has introduced regulatory updates to help clarify and streamline the registration of Therapeutic Products, effective January 16, 2026.
Key updates include:
- A new pathway for submitting Standard Essential Medicines as a Generic Drug Application (“GDA”) for the registration of drugs that are of critical importance to the healthcare system and have established safety and efficacy based on previous clinical experience in Singapore
- Rather than a limit on the number of concurrent Major Variations to a product (MAV-1), which is a type of change submission, the HSA will no longer restrict how many concurrent MAV-1 submissions an applicant may submit. The removal of this limitation means greater flexibility and faster implementation of post-approval product changes, such as clinical indications
- With regards to GMP Conformity Assessments for Drug Substance manufacturing sites located outside Singapore, applicants will now have the option of requesting the HSA to conduct an inspection of their Drug Substance manufacturing site at the time of submitting a New Chemical/Biologic Entity application, if the Drug Substance site has insufficient information to prove its GMP compliance.
- To enhance transparency, expert opinions submitted in support of regulatory applications must include written declarations confirming the absence of conflicts of interest.
- The HSA is continuing its eCTD test submission phase, open until March 27, 2026, to help industry stakeholders familiarize themselves with the electronic submission system ahead of mandatory use in April 2026.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.