postmarketingu

Postmarketing, commonly referred to as postmarketing surveillance or pharmacovigilance, is the monitoring of the safety and real-world performance of a pharmaceutical product after it has been approved and released to the market. Its aim is to detect adverse drug reactions, medication errors, and other risks that may not have been identified in preapproval trials, and to maintain a favorable benefit–risk balance throughout a product’s lifecycle.

Key activities in postmarketing surveillance include spontaneous adverse event reporting, routine literature monitoring, and active surveillance methods such as cohort event monitoring or post-authorization safety studies (PASS). Data are gathered from healthcare professionals, patients, electronic health records, and claims databases. Signals are detected through pharmacovigilance data mining and expert evaluation, then assessed for causality and managed through risk communication, labeling changes, targeted safety communications, or, in some cases, restricted use or withdrawal from the market.

Regulatory frameworks vary by country but share core goals: to continuously assess safety after market entry and to require ongoing safety reporting, periodic safety updates, and risk management plans. Agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national authorities oversee postmarketing programs, often coordinating with international networks and databases like VigiBase and EudraVigilance.

The field supports ongoing vigilance of medicines in diverse populations and real-world settings but faces challenges such as under-reporting, data quality limitations, reporting biases, and the need for timely analysis. Effective postmarketing surveillance relies on robust data systems, transparent communication, and coordinated regulatory action.