Post Market Surveillance (PMS) is a critical component of the regulatory framework enforced by the FDA Philippines. It involves the continuous monitoring of products that are already on the market to ensure its safety, efficacy, and quality. This process helps identify any issues that may arise after the product has been approved and distributed to consumers.

Key Elements:

1. Adverse Event Reporting:

• Manufacturers, importers, distributors, and healthcare professionals are required to report any adverse events or product defects to the FDA Philippines.
• Consumers can also report adverse events directly to the FDA.

 

2.Periodic Safety Update Reports (PSUR):

• Companies must submit regular updates on the safety profile of their products, including any new information on adverse effects and actions taken to mitigate risks.

 

3.Product Recalls and Withdrawals:

• The FDA has the authority to recall products if they are found to be unsafe, ineffective, or of poor quality.
• Companies are responsible for promptly informing the FDA of any need to recall or withdraw products and for conducting these actions efficiently.

 

4.Inspection and Audits:

• The FDA conducts routine and for-cause inspections of manufacturing facilities, warehouses, and distribution channels to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards.

 

5.Market Monitoring:

• Regular surveillance of products in the market, including testing and analysis, to ensure ongoing compliance with quality standards.
• Random sampling and testing of products available to consumers.

 

6.Pharmacovigilance:

• Specifically for pharmaceutical products, pharmacovigilance activities involve the collection, analysis, and interpretation of data on adverse drug reactions and other drug-related problems.

Compliance and Penalties

Non-compliance with PMS requirements can result in penalties, including fines, suspension, or revocation of product registrations, and in severe cases, criminal charges. The FDA Philippines emphasizes the importance of PMS in safeguarding public health and maintaining trust in the regulatory system.