In brief
On 28 January 2026, the Health Sciences Authority (HSA) issued Version 3 of its product defect reporting and recall procedures for therapeutic products (TPs) and cell, tissue and gene therapy products (CTGTPs). The HSA, through the updated guidance, does the following:
- Provides some clarification on the scope of product recalls and reportable defects
- Clarifies and reorganises certain portions of the guidance
- Highlights certain key issues to take note of
- Creates a new product defect reporting form for defects relating to clinical research materials used in clinical trials
- Expands the annexures substantially
In more detail
Clarifications on the scope of product recalls and reportable defects
The HSA has made several clarifications on the scope of the guidance, particularly the following:
- The definition of “recall” now expressly excludes the retrieval of expired products not due to product defects and the retrieval of a small quantity of products for investigative purposes.
- Out of specification (OOS) results related to stability commitment batches from previous variation applications are now expressly listed as an example of a reportable defect.
Clarifications and reorganisation of the guidance on investigations and risk assessments
The HSA previously included a list of information and actions that are required in the investigation report during the risk assessment. It has now expanded the “Investigation and risk assessment” section to include specific guidance on the components of the investigation, considerations of the risk assessment, what to include in the investigation report, explanations on the distribution and supply information.
Reiteration of the proper product defect reporting procedure
The HSA has emphasised that, while minor variation (MIV) applications may be required as part of the CAPA, they do not substitute the need to first notify the HSA of the defect via the product defect reporting form.
New product defect reporting form for clinical research materials used in clinical trials
The HSA has also provided a link to a new product defect reporting form for applicants and clinical trial sponsors to report defects.
Updated annexures
Finally, the HSA has also considerably supplemented its annexures by including the following information:
- Under Annex II, the HSA elaborates on the requirements for supplying an OOS batch of CTGTP, also adding a new subsection on the scope of applicability while reorganising previous content under clearer subheadings.
- Under Annex III, the HSA consolidates guidance on recommended contents for Dear Purchaser Letters and Dear Healthcare Professional Letters with expanded elaborations.
Under Annex V, the HSA consolidates guidance on consumer-level recalls, mandating notifying the HSA immediately upon deciding to initiate a consumer-level recall. This is justified on the basis that these recalls typically require additional preparation, coordination and regulatory oversight.
Key takeaways
The updated guidance provides clear and structured guidance regarding the entire product defect reporting, investigation, risk assessment, corrective and preventive actions (CAPA), and recall process for TPs and CTGTPs. It is likely that the HSA has refined its guidance on product defect reporting and recall based on deficiencies from past product registrants and dealers in such situations. Product registrants and dealers should familiarise themselves with the updated product defect reporting and recall procedures to ensure compliance with applicable requirements.
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