What is required during Post Marketing Surveillance (PMS)?

Post Marketing Surveillance (PMS) is essential for ensuring the ongoing safety and efficacy of products that have already received regulatory approval and are available on the market. The primary focus of PMS is the ongoing safety monitoring of these approved products. This involves collecting and analyzing data related to adverse events, product performance, and other relevant safety information after the product has been launched to identify any potential risks or issues that may arise once the product is in widespread use.

The ongoing safety monitoring helps in assessing the long-term effects of a product and determining if additional risk mitigation measures are necessary, such as updates to labeling or the implementation of Risk Evaluation and Mitigation Strategies (REMS). This function is crucial for protecting public health, as it allows regulatory agencies to act swiftly if new safety concerns are identified.

While conducting market research studies, updating marketing strategies, and conducting intensive pre-market evaluations are important aspects of the product lifecycle, they do not fall under the purview of post-marketing surveillance. PMS specifically targets the realities of product use in the market, rather than pre-approval activities or strategic marketing initiatives.