Post Marketing Commitments (PMCs)

What are post marketing commitments? 

Post marketing commitments (PMCs) are obligations set by regulatory agencies, such as the U.S. Food and Drug Administration (FDA), that require pharmaceutical companies to conduct additional studies or surveillance after a drug or medical device has been approved and brought to market. These commitments often arise when there is a need for further data on the long-term safety, efficacy, or risk profile of a product that was not fully addressed during pre-market clinical trials. 

Why are post marketing commitments important? 

Post marketing commitments are essential for ensuring the continued safety and efficacy of medical products once they are available to the public. These studies help identify any potential risks or side effects that were not evident in pre-approval clinical trials, particularly those related to long-term use, rare conditions, or specific subpopulations. They help maintain public trust, guide physicians in prescribing practices, and ensure that regulatory agencies have the most up-to-date information.