Regulatory Updates: Guidance on Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products (effective 28 Jan 2026)

As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in our regulatory requirements and processes, the Vigilance and Compliance Branch, Health Products Regulation Group, has updated the “Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products”. Key updates include:

1. Clarifications on reportable and non-reportable defects

2. Updated guidance on investigation and risk assessment of product defects

3. Clarification that MIV applications should not be used as a mechanism for reporting product defects to HSA

4. Updated guidance on notification of recall actions to stakeholders 

5. New Product Defect Reporting Form for Clinical Trial Products

6. Updated and new Annexes:

a. Clarifications on conditions for supply involving out of specification batch of CTGTP
b. New Annex on recommended contents for Dear Purchaser Letter and Dear Healthcare Professional Letter
c. New Annex on guidance for conduct of consumer-level recalls detailing the responsibilities and the required actions of the company conducting the recall

The updated version can be accessed at the webpage “Product defect reporting and recall procedures for therapeutic products”

Vigilance and Compliance Branch
Health Products Regulation Group