The Expanding Scope of Pharmacovigilance

The original PV mandate covered small-molecule synthetic drugs reported by healthcare professionals. That scope has expanded substantially: vaccines & AEFI, biologics & biosimilars, ATMPs (gene/cell therapies), herbal & traditional medicines, medical devices, and digital therapeutics (SaMD) now all sit under the same core PV discipline.

Biological medicines present unique challenges — small manufacturing changes can alter immunogenicity, and biosimilars are not identical to the reference product, so ICSRs must capture brand name and batch number, not just the INN. ATMPs may be single-dose with lifelong effects and require follow-up often exceeding 15 years. Herbal and traditional medicines present a different challenge entirely — sold without prescription, often not reported by users as "medicines" at all — hepatotoxicity from kava, comfrey, and aristolochic acid demonstrates that "natural" does not mean safe. And Software as a Medical Device — AI algorithms that influence clinical decisions — is the newest frontier, increasingly regulated with its own post-market surveillance requirements.

The common thread across every one of these expansions is that PV’s core logic — detect, assess, understand, prevent — doesn’t change; what changes is where the signal comes from and how hard it is to attribute. A batch-specific manufacturing defect in a biologic, a genetic risk factor in a gene therapy, or an undisclosed herbal supplement interacting with a prescription drug are all, structurally, the same kind of problem PV has handled since 1968 — just with a wider range of products and a wider range of places a signal might first surface.