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

Feel free to share with your peers and if you need ad-hoc support in PV front, get in touch!

As pharmaceutical products directly impact patient health and well-being, maintaining high-quality standards is essential. Medications should always be safe, effective and consistent in their therapeutic effects to avoid potential risks such as treatment failures, adverse reactions or even life-threatening consequences. 

This is where Good Distribution Practice (GDP) for pharmaceutical products comes in handy, guaranteeing the quality and integrity of medicinal solutions as they move through the supply chain from manufacturer to end-user. It encompasses a set of guidelines, involving practices and procedures aimed at maintaining appropriate storage, transportation and handling conditions to prevent compromising the safety, efficacy or quality of the products. In this article, we take a look at how pharmaceutical organisations can ensure GDP to uphold their reputation and build greater trust with their customers.

Good Pharma Registration 

While good pharma registration focuses on the initial assessment of a product’s suitability for market entry, it still influences GDP by establishing standards and requirements that products must meet throughout their lifecycle. As such, a comprehensive understanding of a product’s characteristics gained during registration, including stability profiles and storage requirements, is essential when it comes to the formulation of distribution protocols. These protocols ensure the maintenance of product integrity during transportation, warehousing and handling. For instance, if a medication is found to be sensitive to temperature fluctuations during the registration process, specific storage and transportation requirements may be mandated to safeguard the product’s effectiveness and safety for patient use.

Learn more: Top 6 Tips for Successful Pharma Registration in Singapore

At The Reg Consultants, we understand the importance of proper pharma registration in the ASEAN region for market approval and distribution. Our subscription plans for regulatory affairs are specially designed to help you streamline the registration process and comply with regional regulations.  

Quality Management System

A Quality Management System (QMS) in the pharmaceutical industry is an all-encompassing framework comprising processes and resources covering document control, risk management, change control, and validation protocols. GDP requires the implementation of a robust QMS to ensure all aspects of distribution operations adhere to established standards and procedures. A QMS helps to identify, assess and mitigate risks associated with product handling, storage, transportation and documentation, playing a pivotal role in maintaining product integrity and regulatory compliance. Regular audits, inspections, and performance evaluations are also integral components of the QMS, enabling ongoing verification of GDP adherence and identification of areas for enhancement. Additionally, training programmes embedded within the QMS equip personnel with the knowledge and skills necessary to execute their roles in accordance with GDP guidelines. 

However, setting up your QMS documentation can be tedious and time-consuming, which is why enlisting the help of professionals is always recommended. Our regulatory consulting services include QMS documentation set-up, making it easier for your products to gain regulatory approval and achieve the highest industry standards. 

Post-Licensing Activities

Though the majority of pharmaceutical organisations may dedicate more of their time and effort to the initial stages of gaining product distribution approval, post-licensing activities are equally crucial. These activities make sure that products continue to meet regulatory standards, safeguarding product integrity. Post-licensing activities like renewals, variations, change notifications and market recall activities directly impact GDP by influencing the regulatory status, documentation, handling procedures and distribution protocols of pharmaceutical products. For example, renewals and variations require thorough documentation and adherence to regulatory requirements, which contribute to the proper management of distribution operations. Change notifications help maintain transparency and accountability in the distribution process, appropriately communicating and addressing any changes affecting product quality or safety. Similarly, market recall activities are essential for mitigating risks to patient safety and upholding the integrity of the supply chain. 

With expertise in regulatory consulting for pharma, The Reg Consultants is here to support you across all touchpoints of your distribution journey even after successful market entry. Our post-licensing services include renewal, variations, change notifications, and market recall activities, assuring your products remain compliant with evolving laws and guidelines.

An indispensable tool in the world of pharmaceutics, GDP serves as a useful structure to safeguard patient health and well-being. Leverage the above tips to maintain product quality and efficacy, from production to consumption, for seamless market access in your next pharma distribution venture!

The Reg Consultants specialises in pharma regulatory services. We prioritise the safety of each pharmaceutical product, ensuring compliance with Good Distribution Practices (GDP), ISO 13485, and ISO 9001 requirements. Contact us today for more information.