What do Post Marketing Requirements (PMR) require sponsors to conduct?

Post Marketing Requirements (PMRs) are specific conditions set by regulatory authorities that compel sponsors to conduct studies and clinical trials after a product has received market approval. These studies are critical for evaluating the long-term safety, efficacy, and optimal use of a product in the general population. The purpose of PMRs is to gather additional data that may not have been available during the pre-market evaluation, ensuring ongoing assessment of the product's risk-benefit profile once it is on the market.

The requirement for studies and clinical trials allows sponsors to monitor the real-world performance of their product, ensuring that any unforeseen issues can be identified and addressed promptly. This is particularly important for products that are used widely and may encounter varied patient responses or rare adverse events that were not fully characterized in the pre-marketing phase.

While surveys, market analytics, and pre-marketing validations can provide useful information, they do not fulfill the specific obligations of PMRs, which are intended to gather rigorous scientific data through direct studies. The emphasis of PMRs is on generating new evidence rather than analyzing existing data or user feedback.