Regulatory Updates
Industry Training Workshop on (i) Product Defect Reporting and Recall Procedures, and (ii) Management of Nitrosamine Impurities in Therapeutic Products
Audiences
Industry member
Product type
Cell, Tissue and Gene Therapy Products
Therapeutic Products
28 April 2025
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The Vigilance and Compliance Branch (VCB) conducted an online industry training workshop on 29 and 30 October 2024. The objectives of the workshop were to:
Provide a comprehensive overview of the procedures and requirements of product defect reporting and recall for therapeutic products and cells, tissue and gene therapy products; and
Clarify HSA’s current approach, recommendations, and regulatory requirements for managing nitrosamine impurities in therapeutic products.
We appreciate industry stakeholders’ active participation during the Q&A sessions. We have made the following resources available on the HSA website:
Day 1 (29 October 2024) – Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products
Presentation slides - Product Defect Reporting and Recall Procedures [PDF, 2 MB] (opens in new tab)
Workshop recording - Product Defect Reporting and Recall Procedures (opens in new tab)