3. Enumerate the different triggers of product recall and briefly explain each. • Health product quality/complaints processing - • Adverse Events (AEs) monitoring and Events-based Surveillance Response (ESR) reports – reports ADR or unexpected harmful

Product recalls can be triggered by a variety of factors related to health product quality, safety, and compliance. Each trigger serves to protect consumers and ensure that products in the market meet established safety and quality standards. Here’s an enumeration and brief explanation of the different triggers of product recall:

**Health Product Quality/Complaints Processing**: This involves monitoring consumer complaints and quality issues reported by healthcare professionals or patients. If a significant number of complaints arise regarding product defects or quality issues, an investigation may lead to a recall to address potential health risks.

**Adverse Events (AEs) Monitoring and Events-based Surveillance Response (ESR) Reports**: Regulatory agencies monitor reports of adverse drug reactions (ADRs) and unexpected harmful effects. If a review confirms that certain risks associated with a product are legitimate and pose a threat to patient safety, a recall may be initiated to mitigate harm.

**Sampling, Testing, and Verifying Health Products**: The FDA and other regulatory bodies may conduct laboratory tests on health products. If contamination, failure to meet safety standards, or adulteration is discovered during testing, a recall is often necessary to protect consumer health.

**Post-Licensing Inspection, Monitoring, and Investigations**: After a product has been licensed, ongoing inspections and monitoring are conducted to ensure compliance with safety and quality standards. If violations are found during these evaluations, a recall may take place.

**Post-Evaluation of Acknowledged Notifications**: This involves reviewing any notifications or warnings issued regarding potential health risks associated with a product. If significant risks are validated, a recall will be enacted to ensure consumer safety.

**Advertisements and Promotional Articles Monitoring**: Monitoring marketing materials is important to ensure that advertising claims are accurate and not misleading. If products are promoted in a way that endangers consumer safety or fails to disclose risks, recalls can be initiated to correct misinformation.

**Coordination with Regulatory Agencies and International Partners**: Collaboration with other regulatory bodies and international health organizations helps identify global safety issues. If a product poses a risk across borders, a recall can be initiated in cooperation with various agencies.

**Pharmacovigilance (PV)**: This is the science of monitoring the effects of pharmaceutical products after they have been released on the market. Regular and systematic data collection about drug usage and effects can lead to identifying safety issues and triggering recalls when risks are identified.

**Defective Product Reports from Reputable Sources**: Information from sources such as the ASEAN Post-Marketing Alert System (PMAS) facilitates the reporting of defects and quality issues. When credible reports emerge indicating that a product is defective or harmful, regulatory authorities may initiate a recall.

**Product Information File Audits**: Regulatory agencies perform audits of the product information files submitted by manufacturers. If discrepancies or issues related to product safety or efficacy are discovered during these audits, a recall may be warranted to address any confirmed problems.

Together, these triggers ensure that health products remain safe for consumer use, and effective processes are in place to address any issues that arise post-market.