Skip to main content

Postmarketing Requirements (PMRs)

Meaning

Postmarketing Requirements (PMRs) are studies or clinical trials that regulatory agencies mandate a pharmaceutical company to conduct after a drug has received initial approval for marketing. These requirements are imposed to gather additional data on the drug’s safety, efficacy, or optimal use in specific populations or long-term scenarios not fully addressed during the pre-approval phase. PMRs are a crucial component of the continuous surveillance and risk management strategy for new hormonal therapies and medications. They reflect the agency’s commitment to ongoing evaluation of the product’s risk-benefit profile in the broader patient population.