Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities.

Zusammenfassung

As pharmaceutical development spans multiple continents, marketing authorization holders must simultaneously comply with distinct adverse event reporting frameworks of major health authorities. Although International Council for Harmonisation guidelines provide shared foundations, meaningful differences persist in reporting timelines, case thresholds, and special-situation obligations across jurisdictions. A narrative review of primary regulatory legislation, guidance documents, peer-reviewed li