Singapore HSA updated Guidance for Post-marketing Vigilance Requirements for Therapeutic Products and Cell, Tissue and Gene Therapy Products (CTGTP), effective 1 April 2026.
Apart from editorial changes made, the following areas
Regulatory News
Singapore HSA Announces eCTD Format Officially Accepted for Therapeutic Products Regulatory Dossier Submission
Singapore HSA announces that electronic Common Technical Document (eCTD) format will be officially accepted for Therapeutic Products regulatory dossier submission with effect from 1 April 2026. Companies may continue with
Singapore HSA Updates Guidance on CTGTP Registration and Variation Applications
Health Sciences Authority (HSA) has updated the Guidance on Cell, Tissue or Gene Therapy Product (CTGTP) Registration and Variation Applications in Singapore, as well as the related Minor Variation (MIV)
Singapore HSA and Malaysia MDA Jointly Launches Medical Device Regulatory Reliance Programme
The Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore signed a Memorandum of Understanding (MoU) during the 14th ASEAN Medical Device Committee (AMDC) Meeting
Singapore HSA Updates Guidance on Product Defect Reporting and Recall Procedures for Therapeutic Products and CTGTP
As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in Singapore’s regulatory requirements and processes, the Vigilance and Compliance Branch, Health Products Regulation Group, has updated
Malaysia NPRA Updates Drug Registration Guidance Document (DRGD) Regarding Variation Application of Registered Products: Processing Time Period for All Product Categories and Introduction of Reliance Mechanism for Pharmaceutical Products
Malaysia NPRA has release circular on Drug Registration Guidance Document (DRGD) guideline Updates on Variation application processing timeline for all registered products including all product categories and Introduce Reliance Mechanism
Singapore HSA Updates Therapeutic Product Registration Guidelines
As part of Singapore HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in regulatory requirements and processes, the Therapeutic Products Branch (TPB), Health Products Regulation Group, has updated
Singapore HSA Updates Guidelines on Software Medical Devices (GL-04)
The revised guideline includes several key changes:
Document title has been updated to include machine learning-enabled medical devices.
New and revised definitions have been added for “Machine Learning”, “AIMD”, “Cybersecurity”,
Malaysia MDA Updates Policy on Conformity Assessment Procedures for Medical Device approved by recognised countries
Malaysia MDA has released an updated version of its Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification.
As part of the revision, the MDA has expanded