Overview of Product Defect Reporting in Singapore

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Product Registrant Responsibilities
In Singapore, the Marketing Authorization Holder (MAH), also known as the Product Registrant, is responsible for ensuring that products released into the market are safe and of high quality. This obligation includes pharmacovigilance (PV) activities such as monitoring safety profiles, adverse event reporting, active surveillance programs, and compiling Periodic Benefit-Risk Evaluation Reports (PBRER).

Key Pharmacovigilance Activities

1. Monitoring Safety Profiles: Detecting and evaluating signals from product usage.
2. Adverse Event Reporting: Documenting and reporting any adverse reactions associated with product use.
3. Active Surveillance Program: Proactively monitoring products in the market.
4. Periodic Benefit-Risk Evaluation Reports (PBRER): Regularly assessing the benefit-risk profile of products.

Product Defect Reporting Process

Classification of Product Defects
Product complaints, also known as product defect reports, are classified into two categories:

1. Critical Defects:
   • Pose a serious threat to user or public health.
   • May lead to severe injury or death.
   • Must be reported within 48 hours, excluding weekends.
2. Non-Critical Defects:
   • Do not pose a critical threat but may affect treatment outcomes or product quality.
   • Must be reported within 15 calendar days.

Reporting Requirements
All product defect reports must be submitted through the online form provided by the regulatory authority (link). The initial report should contain comprehensive information, including:

1. Product details.
2. Description of the defect.
3. Affected batch numbers and quantity.
4. Date of occurrence.
5. Expiry date of affected batches.
6. Date of last distribution.
7. Details of the reporter.

An investigational report and Corrective and Preventive Actions (CAPA) plan must follow the initial report, submitted within one month.

Post-Reporting Actions

Based on the initial and investigational reports, the following actions may be taken:

1. Product Recall:
   • Removing defective products from the market.
   • Notification of the recall must be sent to the authority within 24 hours.
2. Dear Purchaser Letter (DPL):
   • Informing purchasers about administrative or logistical details of the recall.
3. Dear Healthcare Professional Letter (DHCPL):
   • Notifying healthcare professionals about significant safety, quality, or efficacy issues.
4. Press Release:
   • Issued if necessary to inform the public.
5. Suspension or Cancellation of Product Registration:
   • May occur if the defect is severe enough to warrant market removal.

Final Reporting
Companies must keep the regulatory authority informed throughout the recall process and submit a product recall completion form along with a reconciliation report to close the incident.

This overview provides a structured approach to handling product defect reporting in Singapore, ensuring that all necessary steps are followed to maintain public health and safety.

For more information: refer to :

 Product Defect Reporting Guideline

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