HSA revises Guidance on Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products

26 February 2026

On 28 January 2026, the Health Sciences Authority (“HSA”) published a revised version of the Guidance on Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products (“Guidance”). 

The revision, by the Vigilance and Compliance Branch of the Health Products Regulation Group, is part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in its regulatory requirements and processes.

Key updates include: 

  • clarifications on reportable and non-reportable defects; 
  • updated guidance on investigation and risk assessment of product defects;
  • clarification that minor variation applications should not be used as a mechanism for reporting product defects to HSA; 
  • updated guidance on the notification of recall actions to stakeholders; and 
  • a new product defect reporting form for clinical trial products. 

The revised Guidance also includes updated and new Annexes, including: 

  • clarifications on the conditions for the supply of an out of specification batch of cell and tissue gene therapy products for clinical use; 
  • a new Annex on recommended contents for Dear Purchaser Letters and Dear Healthcare Professional Letters; and 
  • a new Annex providing guidance for the conduct of consumer-level recalls detailing the responsibilities and the required actions of the company conducting the recall. 

Reference materials 

The following materials are available on the HSA website www.hsa.gov.sg: