Briefly
On 28 January 2026, the Well being Sciences Authority (HSA) issued Model 3 of its product defect reporting and recall procedures for therapeutic merchandise (TPs) and cell, tissue and gene remedy merchandise (CTGTPs). The HSA, by way of the up to date steerage, does the next:
- Supplies some clarification on the scope of product recollects and reportable defects
- Clarifies and reorganises sure parts of the steerage
- Highlights sure key points to be aware of
- Creates a brand new product defect reporting kind for defects regarding scientific analysis supplies utilized in scientific trials
- Expands the annexures considerably
In additional element
Clarifications on the scope of product recollects and reportable defects
The HSA has made a number of clarifications on the scope of the steerage, significantly the next:
- The definition of “recall” now expressly excludes the retrieval of expired merchandise not because of product defects and the retrieval of a small amount of merchandise for investigative functions.
- Out of specification (OOS) outcomes associated to stability dedication batches from earlier variation purposes are actually expressly listed for instance of a reportable defect.
Clarifications and reorganisation of the steerage on investigations and danger assessments
The HSA beforehand included a listing of data and actions which might be required within the investigation report through the danger evaluation. It has now expanded the “Investigation and danger evaluation” part to incorporate particular steerage on the parts of the investigation, issues of the danger evaluation, what to incorporate within the investigation report, explanations on the distribution and provide info.
Reiteration of the right product defect reporting process
The HSA has emphasised that, whereas minor variation (MIV) purposes could also be required as a part of the CAPA, they don’t substitute the necessity to first notify the HSA of the defect by way of the product defect reporting kind.
New product defect reporting kind for scientific analysis supplies utilized in scientific trials
The HSA has additionally offered a hyperlink to a brand new product defect reporting kind for candidates and scientific trial sponsors to report defects.
Up to date annexures
Lastly, the HSA has additionally significantly supplemented its annexures by together with the next info:
- Below Annex II, the HSA elaborates on the necessities for supplying an OOS batch of CTGTP, additionally including a brand new subsection on the scope of applicability whereas reorganising earlier content material beneath clearer subheadings.
- Below Annex III, the HSA consolidates steerage on beneficial contents for Pricey Purchaser Letters and Pricey Healthcare Skilled Letters with expanded embellishments.
Below Annex V, the HSA consolidates steerage on consumer-level recollects, mandating notifying the HSA instantly upon deciding to provoke a consumer-level recall. That is justified on the premise that these recollects sometimes require extra preparation, coordination and regulatory oversight.
Key takeaways
The up to date steerage gives clear and structured steerage relating to all the product defect reporting, investigation, danger evaluation, corrective and preventive actions (CAPA), and recall course of for TPs and CTGTPs. It’s possible that the HSA has refined its steerage on product defect reporting and recall based mostly on deficiencies from previous product registrants and sellers in such conditions. Product registrants and sellers ought to familiarise themselves with the up to date product defect reporting and recall procedures to make sure compliance with relevant necessities.
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Briefly
On 28 January 2026, the Well being Sciences Authority (HSA) issued Model 3 of its product defect reporting and recall procedures for therapeutic merchandise (TPs) and cell, tissue and gene remedy merchandise (CTGTPs). The HSA, by way of the up to date steerage, does the next:
- Supplies some clarification on the scope of product recollects and reportable defects
- Clarifies and reorganises sure parts of the steerage
- Highlights sure key points to be aware of
- Creates a brand new product defect reporting kind for defects regarding scientific analysis supplies utilized in scientific trials
- Expands the annexures considerably
In additional element
Clarifications on the scope of product recollects and reportable defects
The HSA has made a number of clarifications on the scope of the steerage, significantly the next:
- The definition of “recall” now expressly excludes the retrieval of expired merchandise not because of product defects and the retrieval of a small amount of merchandise for investigative functions.
- Out of specification (OOS) outcomes associated to stability dedication batches from earlier variation purposes are actually expressly listed for instance of a reportable defect.
Clarifications and reorganisation of the steerage on investigations and danger assessments
The HSA beforehand included a listing of data and actions which might be required within the investigation report through the danger evaluation. It has now expanded the “Investigation and danger evaluation” part to incorporate particular steerage on the parts of the investigation, issues of the danger evaluation, what to incorporate within the investigation report, explanations on the distribution and provide info.
Reiteration of the right product defect reporting process
The HSA has emphasised that, whereas minor variation (MIV) purposes could also be required as a part of the CAPA, they don’t substitute the necessity to first notify the HSA of the defect by way of the product defect reporting kind.
New product defect reporting kind for scientific analysis supplies utilized in scientific trials
The HSA has additionally offered a hyperlink to a brand new product defect reporting kind for candidates and scientific trial sponsors to report defects.
Up to date annexures
Lastly, the HSA has additionally significantly supplemented its annexures by together with the next info:
- Below Annex II, the HSA elaborates on the necessities for supplying an OOS batch of CTGTP, additionally including a brand new subsection on the scope of applicability whereas reorganising earlier content material beneath clearer subheadings.
- Below Annex III, the HSA consolidates steerage on beneficial contents for Pricey Purchaser Letters and Pricey Healthcare Skilled Letters with expanded embellishments.
Below Annex V, the HSA consolidates steerage on consumer-level recollects, mandating notifying the HSA instantly upon deciding to provoke a consumer-level recall. That is justified on the premise that these recollects sometimes require extra preparation, coordination and regulatory oversight.
Key takeaways
The up to date steerage gives clear and structured steerage relating to all the product defect reporting, investigation, danger evaluation, corrective and preventive actions (CAPA), and recall course of for TPs and CTGTPs. It’s possible that the HSA has refined its steerage on product defect reporting and recall based mostly on deficiencies from previous product registrants and sellers in such conditions. Product registrants and sellers ought to familiarise themselves with the up to date product defect reporting and recall procedures to make sure compliance with relevant necessities.
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