Post-Marketing Surveillance — Where PV Lives

Post-marketing pharmacovigilance is where the safety story of a medicine is written in full. The controlled clinical-trial environment has ended — the product now reaches elderly patients, pregnant women, patients with renal failure, and patients on complex polypharmacy regimens who were excluded from trials. This data environment is messy and confounded — and it is also precisely where the most clinically relevant safety signals emerge.

Spontaneous reporting by healthcare professionals and patients remains the backbone of post-marketing PV, despite an estimated 94% median underreporting rate. Its value isn’t in absolute numbers — it’s the ability to generate hypotheses about novel drug-event associations, which is exactly how the rofecoxib cardiovascular signal and the carbamazepine HLA-B*1502 signal were both first flagged.

Post-Authorisation Safety Studies (PASS) characterise RMP-identified risks, measure real-world incidence, or assess RMM effectiveness — required by regulators or voluntarily initiated. Post-Authorisation Efficacy Studies (PAES) check whether real-world effectiveness matches trial data, which can trigger label revisions when it doesn’t.

PBRERs synthesise all accumulated safety data at defined intervals — every 6 months for the first 2 years, then annually, then less frequently for mature products — into an updated benefit-risk assessment. Under EU Regulation 2025/1466, PBRERs submitted from February 12, 2026 must include mandatory risk minimisation effectiveness evaluation data.