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Product defect reporting and recall procedures for cell, tissue and gene therapy products (CTGTP)

Find out when and how to report or recall defective CTGTP that may potentially cause harm to patients or public health.

Overview

Product defect that affects the safety, quality and efficacy of the product, and may cause potential harm to the patient or public health, must be reported to HSA. A defective product is one that:

  • Has or has possibly been adulterated or tampered with.
  • Is or is possibly an unwholesome health product.
  • Is or is possibly of inadequate quality or unsafe or inefficacious for its intended purpose. 
  • Fails or could possibly fail to satisfy such other standards or requirements as may be prescribed.

Product registrants, manufacturers, importers and suppliers are responsible for the safety, quality and efficacy of their products. They should have systems and procedures in place to investigate, review and report the product defects to HSA, and if necessary, to promptly recall affected products.

Classification of product defect

A defect is classified into either "critical defect" or "non-critical defect" according to the potential impact to public health and the risks posed to the intended user of the product.

Critical defect

Non-critical defect

A defect that can pose a serious threat to the intended users or public health in Singapore. A serious threat means a hazard that occurs in association with the use or administration of a product and that may lead to the death of, or a serious injury to, any person. A defect which does not meet the criteria of “critical defect” but may cause illness or affect the outcome of a person’s medical treatment and/or affect the quality of a product. 

Product defect reporting and recall requirements

Report product defects

Types of defect to report

The company needs to report critical or non-critical defects of:

  • Affected batches which have been imported for supply or supplied in Singapore.
  • Affected batches which the company intends to import into Singapore for supply.

This include defects resulting from manufacturing deviations or non-compliances to Good Manufacturing Practice (GMP) at a manufacturing plant which may be in Singapore or overseas.

Information to be included in the product defect reports

The initial report of product defect should contain as much details as available, but reporting should not be delayed due to the time needed to gather the full information. The minimum information required for the submission of an initial report of product defect is:

  1. Product information.
  2. Description of defect.
  3. Number of the product(s) or batch(es) affected.
  4. Date of occurrence.
  5. Expiry date of affected batch(es).
  6. Date of last distribution of the affected batch(es) to the market.
  7. An identifiable reporter.

Following the initial report, the company will need to submit the investigation report, health hazard assessment, and corrective and preventive actions (CAPA) plan to HSA.

The follow-up investigation and risk assessment report should include the following (but not limited to):

  1. Full description of the defect.
  2. Explain how the defect occurred and the date of occurrence.
  3. Explain how the defect was discovered and the date it was discovered.
  4. Evaluation of samples of the defective product obtained from the complainant (if any).
  5. Local distribution records of affected batches.
  6. Overseas distribution list of affected batches exported from Singapore.
  7. Indicate whether the product was sold under tender contract or pending tender consideration.
  8. Review of batch records and any change controls or deviations associated with the batches.
  9. Review of previous complaints, quality defect reports and relevant information for any indication of recurring problems; whether other similar defect had occurred locally or globally.
  10. Indicate if the defect affects all batches or only selected batches. Review of whether other batches and, if other products could be affected. Explain why the defect affects only selected batches.
  11. List down the regulatory actions taken or to be taken by other regulatory authority or by the company.
  12. Identify possible root causes of the defect.
  13. Health hazard assessment on the potential short-term and long-term consequence of the defect to intended users.
  14. Certificate of Analysis of the affected batch(es).
  15. Examine and test reference and/or retention samples if needed.
  16. Assessment of the appropriate market actions necessary for the affected stocks, including whether it is necessary to quarantine or recall any existing stocks.
  17. Indicate whether there could be a supply shortage as a result of the defect or market action.
  18. Provide description of the Corrective and Preventive Actions (CAPAs) taken or to be taken to prevent a similar defect from recurring.

When to report

Classification of product defect When to report upon becoming aware of the defect
Critical defects Within 48 hours (excluding Sundays and public holidays)
Non-critical defects Within 15 calendar days

How to report

The company can use the Product Defect Reporting Form to report product defect to HSA. 

The completed product defect reporting form and any other accompanying documents must be submitted within stipulated timelines to:

Vigilance and Compliance Branch
Email: HSA_productdefect@hsa.gov.sg

For reporting of product defects in products in clinical trials, please submit reports to:

Innovation Office & Clinical Trials Branch
Email: HSA_CT@hsa.gov.sg

What happens after a defect is reported

Upon receipt of the product defect report, HSA will review the information provided in the report and may request for further information required for assessment. Depending on the potential risk to the intended users or to public health, HSA may require additional risk control measures, such as:

  • A product recall.
  • Issuance of a Dear Purchaser Letter
  • Issuance of Dear Healthcare Professional Letter.
  • Issuance of a press release.
  • Suspension or cancellation of the product registration.

Recall products

When to initiate a product recall

When a defective product is considered to present a risk to the intended user or public health, HSA may require company to remove it from the market by recalling the affected batches or all batches of the product in extreme cases.

Company may also initiate a product recall for other reasons such as commercial reasons.

Product recall classification

The classification of a product recall will depend on the severity of the defect and its impact on a person's health.

Class 1 recall

A Class 1 recall involves the use or exposure to a product with a critical defect that may reasonably lead to serious adverse health consequences or death.

Class 2 recall

A Class 2 recall involves the use or exposure to a product with a non-critical defect that results in either one of the following scenarios:

  • Temporary or medically reversible adverse health consequences.
  • Remote probability of serious adverse health consequences.

Level of recall

The level of product recall describes the action required based on the extent of distribution of the affected product and potential hazard to public health.

Consumer level

  • Usually initiated when the risk to patients or consumers is assessed to be unacceptable, and where the product is directly supplied to consumers.
  • All wholesale and retail supply of the affected products or batches should be suspended.
  • Affected products or batches are to be recalled from all wholesale and retail distributors as well as patients/consumers who had been supplied with the affected products or batches.
  • Where necessary, the recall notification to consumers may need to be done via announcement on mass media such as press announcement, newspaper notification, television and/or radio (e.g. recall of a General Sales List medicine where it is not possible to contact patients/consumers who had been supplied with the affected products or batches, or recall of a product that had been widely supplied to consumers/patients).

Retail level

  • Usually initiated when the risk to patients or consumers is assessed to be moderate to high.
  • All wholesale and retail supply of the affected products or batches should be suspended.
  • Affected products or batches are to be recalled from all wholesale and retail distributors including:
    • Restructured and private hospital pharmacies.
    • Wholesale distributors
    • Retail pharmacies.
    • Medical, dental and other healthcare practitioners' establishments.
    • Community hospitals, nursing homes and other related institutions.
    • Other retail outlets, such as health food stores and supermarkets.

Wholesale level

  • Usually initiated when the risk to patients or consumers is assessed to be low or where other measures can be taken to mitigate the risk e.g. visual inspections or other interventions by healthcare professionals before supply to patients, or in situations to prevent disruption in supply of a critical product.
  • All wholesale supply of the affected products or batches should be suspended. Affected products or batches are to be recalled from:
    • All wholesalers.
    • All distributors.
    • All third-party logistics providers holding product to distribute to retailers etc.

The recalled products or batches should be segregated in a secured area before the implementation of follow-up actions e.g. destruction of the products.

When to notify HSA on the intended recall

Company does not need to seek approval from HSA for initiating the recall but must notify HSA of the intended recall no later than 24 hours (excluding Sundays and public holidays) before the start of the intended recall i.e. issuance of a notice to the customers or public.

Recall timelines

Recall steps Class 1 recall Class 2 recall
Notify HSA No later than 24 hours* prior to the start of the intended recall.   No later than 24 hours* prior to the start of the intended recall.  
Issue Dear Purchaser Letter Within 1 day* of recall commencement  Within 3 days* of recall commencement 
Issue Dear Healthcare Professional Letter  Where required, within 1 day* of recall commencement  Where required, within 3 days* of recall commencement 
Complete recall process Within 1 week, unless otherwise justified Within 3 weeks, unless otherwise justified

*excluding Sundays and public holidays.

 

Product recall process

Stages Details
Initiate recall

Company initiates a product recall as a result of reports of product defects from healthcare professionals and the public.

Company provides a list of supplied customers in an electronic spreadsheet format (e.g. Microsoft Excel file) to HSA.

Follow recall process and procedures

The requirements for the management of recall, including the types of records that should be kept for supply chain traceability, as well as sale and distribution records of wholesale or retail supply, are described in the Health Products (Cell, Tissue and Gene Therapy Products) Regulation.

The PIC/S GMP Guide and/or HSA Guidelines on Good Manufacturing Practice For Cell, Tissue And Gene Therapy Products stipulate the establishment of written procedures which will be implemented as the need for a recall by the manufacturer arises. HSA Guidance Notes on Good Distribution Practice also stipulates the establishment of written recall procedures by the importers and wholesalers of CTGTP.

Notify stakeholders of recall actions Company communicates the presence of defects and the recall actions to be taken to the customers through appropriate means.

A Dear Purchaser Letter is a letter issued by the company to its purchasers (such as hospitals, clinics, retail stores) to alert them to the administrative or logistic matters related to the product recall.

The Dear Purchaser Letter should include (but not limited to) the following information:

  • Audience / targeted recipient.
  • Purpose of letter.
  • Product details (brand name, active ingredient, affected batch number, product image, images to guide where to find the batch details, if needed).
  • Description of issue, reason for recall and any potential health hazards.
  • Level of recall (wholesale or retail level)
  • Instruction to customers e.g. remove product from sale, cease distribution, return product, conduct sub-recall if appropriate.
  • Refund mechanism.
  • Company’s contact.
  • Return response card / form which includes a space for purchaser’s signature and date to acknowledge the recall and that they have followed through the recall instructions.

A Dear Healthcare Professional Letter is issued to notify the healthcare professionals about important new or updated information regarding major safety, quality and efficacy concerns related to the use of a product that presents potential risks to patients or public health. Company can discuss with HSA on the issuance of the Dear Healthcare Professional Letter.

The Dear Healthcare Professional Letter should include (but not limited to) the following information:

  1. Purpose of letter;
  2. Product details (brand name, active ingredient, affected batch number, product image, images to guide where to find the batch details if needed).
  3. Description of the issue, reason for recall and any potential health hazard(s);
  4. Actions required by patients;
  5. Advisories for healthcare professionals on clinical management and monitoring of patients if any; and
  6. Hotline number(s) (and operating hours) whereby healthcare professionals are able to contact the company should they have any additional questions relating to the recall. 
Issue press release

Company may be required to issue a mass media announcement (e.g. newspaper advertisement) to notify the public on the recall in a timely manner, if deemed necessary e.g. critical defects.

Complete recall

Company must keep HSA informed of the progress of the recall action. Company should perform an effectiveness check to verify that the recall communication was received by the customers and that they understood and followed through the recall instructions.

Company needs to furnish the Product Recall Completion Form upon completion of the product recall, together with a report of reconciliation of quantities of each affected batch (i.e. delivered and returned quantities).

As part of the recall completion report, company updates HSA of the completion follow-up actions i.e. submit the certificate of destruction to HSA within 3 months from the completion of the recall. Prior approval for local destruction is not required.

If any other actions are to be taken, specify them on the Product Recall Completion Form and they will be subjected to HSA’s approval.

Reinstatement of supply

Corrective actions need to be performed to address the quality defect and carry out preventive actions to prevent recurrence of the defect in the future before reinstating supply of product.

Quarantined stocks can only be released with HSA's concurrence, when it has been determined that there is no safety risk in the use of the product or after appropriate corrective actions had been taken to address the safety risk.

Guide for the industry

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Video guide

Watch our video guide on product defect and recall reporting and management for products in Singapore. This video brings you through the considerations on whether a product defect needs to be reported to us, and the steps to report the defect.