Life sciences face rising pressure as regulators change expectations
Heightened attention from regulators is reshaping expectations for data governance and third-party oversight in life sciences.
Regulatory uncertainty has long shaped life sciences, but 2025 marked a shift in expectations. Authorities are focusing more on how companies operate in practice. Enforcement activity continues to signal sustained scrutiny.
Regulators across federal and state agencies are coordinating more closely. Attention is centred on digital system validation, AI-supported documentation, reimbursement processes, and third-party oversight. Flexibility in digital tools is no longer assumed.
Inspection priorities now extend beyond manufacturing quality. Regulators are examining governance of automated analyses, review of AI-generated records, and data consistency in decentralised trials. Clear documentation is becoming critical.
A similar shift is visible in reimbursement and data oversight. Authorities want insight into governance behind pricing, reporting, and data handling. Privacy enforcement now focuses on data flows, AI training data, and third-party access.
Looking ahead to 2026, scrutiny is expected to intensify around AI inspection standards and data sharing. Regulators are signalling higher expectations for transparency and accountability. Sound judgement and consistency may prove decisive.
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