Post-Marketing Surveillance

Post-marketing surveillance is the ongoing process of monitoring the safety and effectiveness of a medication, medical device, or other healthcare product after it has been approved for use by regulatory agencies and made available to the public.

The purpose of post-marketing surveillance is to detect and evaluate any adverse effects or other safety concerns that may arise from the use of a product in the general population. It is also used to monitor the effectiveness of a product in real-world use, as opposed to the controlled conditions of clinical trials.

Post-marketing surveillance is typically conducted by the product manufacturer, who is required to report any adverse events to regulatory agencies. The regulatory agencies, in turn, may conduct their own surveillance activities, such as monitoring adverse event reports, conducting inspections of manufacturing facilities, and reviewing clinical data.

In addition to the manufacturer and regulatory agencies, healthcare providers and patients can also play a role in post-marketing surveillance by reporting any adverse events or other concerns they may have about a product.

Overall, post-marketing surveillance is an important component of ensuring the safety and effectiveness of healthcare products, and it plays a key role in maintaining public health.