Postmarket

Postmarket is a term used to describe the phase in a product’s life cycle after it has been released to the market. In regulatory and safety contexts, the postmarket stage focuses on monitoring, evaluating, and managing the ongoing safety, effectiveness, and quality of a product, and on implementing actions based on real-world data.

In pharmaceuticals and medical devices, postmarket activities are typically formalized as post-market surveillance and pharmacovigilance for drugs, or post-market surveillance and post-market clinical follow-up for devices. These activities include collecting and analyzing adverse event reports, conducting safety studies, updating risk management plans, and communicating safety information to stakeholders. Regulators may require labeling changes, corrective actions, or recalls when new risks are identified.

Data sources and methods used in postmarket work include adverse event reporting systems, patient registries, electronic health records, claims data, and spontaneous reports; signal detection and benefit-risk assessment; periodic safety reports; and post-approval studies.

Responsibilities are shared among manufacturers, regulators, healthcare providers, and patients. Manufacturers bear ongoing responsibility for monitoring and reporting; regulators assess data and may mandate actions; healthcare providers and patients contribute by reporting events and observing safety guidance.

Challenges in the postmarket space include underreporting, data quality and interoperability, privacy concerns, costs, and cross-border differences in requirements. Distinctions exist between regulatory postmarket activities and broader business postmarket actions, which focus on after-sales service, warranty management, and product improvements driven by customer feedback.