On July 30, 2025, the Singapore Health Sciences Authority (HSA) made some amendments to the regulatory guidance for the registration of therapeutic products. One of the major updates is changes to the submission checklists for New Drug Applications (NDA), Generic Drug Applications (GDA), and Major Variation (MAV) applications. The checklists apply to both the ICH CTD and ASEAN CTD formats. More specifically, Appendices 2A, 2B, 3A, and 3B were updated to provide clearer guidance and ensure that more comprehensive documentation is obtained at submission.
The HSA also made updates to its screening requirements. Applications will only be accepted for screening if 100% of the required documents are submitted. Any missing documents will cause outright rejection at the screening stage.
For applicants, including pharmaceutical companies and contract research organizations, the registration dossiers will have to be prepared more diligently than in the past. Stakeholders are advised to carefully read the revised appendices to ensure submission packages are fully compliant prior to filing. With stricter initial regulatory requirements, the HSA hopes to reduce the administrative back-and-forth and improve the evaluation timeframe for therapeutic products.
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.