Post-Market Surveillance: Ensuring Ongoing Drug Safety

What is Post-Market Surveillance (PMS)?

Once a drug or medical device enters the market, the responsibility for its safety doesn't end with regulatory approval. Post-Market Surveillance (PMS) is a critical component of pharmacovigilance, ensuring that drugs remain safe for public use by monitoring real-world data after they are available to patients.

At Viltis, our Post-Market Surveillance services are designed to continually track, evaluate, and report on the safety and effectiveness of drugs after they have reached the market. This proactive approach helps identify adverse events that may not have been detected in clinical trials due to limited sample sizes or controlled environments.

How Post-Market Surveillance Contributes to Drug Safety

1. Real-World Data (RWD) Collection: Clinical trials are conducted in controlled settings, but once a drug is available to a wider patient population, unexpected side effects may occur. Post-market surveillance collects real-world data from patients, healthcare providers, and other stakeholders, allowing for a broader understanding of the drug's safety profile in everyday use.

2. Monitoring Adverse Events (AEs): Post-market surveillance captures spontaneous reports of adverse events, which are analyzed to identify safety signals. This data is crucial for detecting rare or long-term side effects that may not have been apparent during pre-approval clinical trials.

3. Risk Management: If safety signals are identified during post-market surveillance, Viltis helps companies develop Risk Management Plans (RMPs) to address the potential risks. This may involve updating drug labels, issuing warnings, or conducting further studies to assess the safety concerns.

4. Regulatory Compliance: Regulatory authorities such as the FDA, EMA, and PMDA require companies to perform post-market surveillance to ensure ongoing compliance with safety standards. Viltis ensures that all surveillance activities comply with global regulatory requirements, protecting your product from potential safety-related withdrawals or fines.

The Importance of Post-Market Surveillance
By continuously monitoring drug performance in real-world settings, Viltis helps pharmaceutical companies identify adverse events early and take action to mitigate risks. Post-market surveillance is not just about regulatory compliance; it's about ensuring that patient safety remains the top priority, even after a product has been approved for widespread use.