Pharmacovigilance Is Not A Checkbox: Rethinking Safety Monitoring From Day One

In most therapeutic categories, sequencing pharmacovigilance planning after commercial strategy is an imperfect but workable approach. In cell and gene therapy, it isn't. The biology changes the stakes: a single infusion can produce effects persisting for years or decades, and regulatory frameworks on both sides of the Atlantic reflect that reality. FDA long-term follow-up guidance for integrating vector products calls for safety monitoring of up to fifteen years post-administration; EMA requirements follow a comparable structure. The infrastructure that supports post-marketing safety monitoring for conventional products cannot be retrofitted to meet those demands.

This article examines why pharmacovigilance in cell and gene therapy requires a fundamentally different approach and what building that infrastructure before launch actually requires.