What is the main objective of post-marketing surveillance in regulatory affairs?

The main objective of post-marketing surveillance is to monitor product performance and safety in the general population. After a product, such as a drug or medical device, has been approved and is available on the market, regulatory authorities continue to track its efficacy and safety. This ongoing assessment is crucial because real-world use may reveal information about adverse effects or other safety issues that were not apparent during clinical trials.

Post-marketing surveillance helps ensure that any potential risks associated with a product are identified and addressed promptly. This includes collecting data about adverse events reported by healthcare providers and patients, analyzing usage patterns, and making necessary regulatory decisions. By focusing on performance and safety in a broader population, regulators can better protect public health and ensure that the benefits of a product outweigh its risks.

Other choices, while they may be important for a business's financial strategy or overall market presence, do not capture the regulatory focus on safety and performance monitoring that is essential to the post-marketing phase.