Post Marketing Surveillance (PMS)

Question

07 Sep 2024

Answer :

Word Count : 626

Post-Marketing Surveillance (PMS) in Drugs Regulatory Affairs refers to the monitoring of a pharmaceutical product's safety, efficacy, and quality after it has been released to the market. This process is crucial for ensuring ongoing patient safety and public health by detecting any adverse effects, rare side effects, or long-term risks that were not identified during the pre-marketing clinical trials.

### Key Aspects of Post-Marketing Surveillance:

1. Purpose: The primary goal of PMS is to continuously assess the safety and efficacy of drugs in a real-world setting. PMS helps to identify unexpected adverse drug reactions (ADRs), interactions with other drugs, and potential issues related to drug misuse, abuse, or off-label use.

2. Methods: PMS involves various activities, including:
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