14 April 2026
Regulators are beginning to explore and pilot artificial intelligence to support internal workflow optimisation and enhanced analytics. While AI is expected to support internal efficiency at agencies such as the FDA, EMA and MHRA, it has not yet produced a predictable, universal reduction in review timelines. Instead, industry experience indicates increasing variability leading to potentially earlier issue identification and tighter windows for strategic tax, legal and corporate planning.
For pharmaceutical and biotech companies preparing late-stage submissions, this means one thing: the traditional assumption of a stable multi month review cycle is no longer dependable. Accelerated approval is now a credible risk scenario, not guaranteed, but sufficiently plausible to require earlier decision-making.
AI enabled review tools are delivering potential gains in consistency and operational throughput. However, this new environment also means:
In parallel with industry adoption, regulators themselves are examining the use of AI to streamline internal processes and enhance decision-making. The European Medicines Agency (EMA) has published a multiannual AI Workplan and a dedicated Reflection Paper outlining expectations for the safe and effective use of AI across the medicinal product lifecycle. These developments, alongside the EU AI Act and Ireland’s forthcoming national implementation, signal a shift toward more structured oversight of AI enabled tools in regulatory submissions.
For life sciences companies, this reinforces the need to embed AI governance, data integrity protocols, and regulatory engagement strategies early in the development process to remain compliant and launch ready under potentially accelerated or variable review timelines.
As a result, planning cycles must now begin earlier in the development process, well before New Drug Applications (“NDA”)/Biologics Applications (“BLA”) submissions.
Historically, companies had a relatively predictable window between NDA submission and approval in which to finalise tax structures, migrate IP, establish manufacturing and distribution models, and complete transfer pricing documentation.
Under the current environment, that window may contract or shift unexpectedly. Companies that delay structural decisions risk:
Earlier decisions are required on the operating model, principal entity vs. limited risk distributors, manufacturing arrangements, IP licensing and risk allocation.
Late drafting of intercompany legal contracts under compressed timelines increases the likelihood of:
Regulatory approval remains a commonly recognised point at which asset value may significantly increase. If approvals come earlier than expected, companies may lose the opportunity to create a corporate structure which allows for a flexible and tax efficient sale or the option to migrate IP at a pre‑approval valuation discount. Shorter regulatory approval timeframes can also allow tax authorities to challenge transaction valuations which may be prepared shortly before regulatory approval is achieved.
Preparing valuation models and migration steps earlier preserves:
Companies should no longer rely on a single regulatory timeline. Instead, they should model:
Key structures, IP, transfer pricing, intercompany legal contracts, supply chain models, must be robust under both scenarios. Preparing early maintains strategic flexibility and prevents value leakage.
KPMG Law supports clients with a fully integrated legal, tax, transfer pricing methodology, aligned to the realities of evolving regulatory review.
Companies that anticipate regulatory uncertainty can expect:
AI is reshaping regulatory operations, not by guaranteeing dramatic accelerations, but by contributing to an environment where timelines may vary and regulatory expectations continue to evolve. For life sciences companies, this means traditional planning windows can no longer be relied upon.
Frontloading legal, tax, IP and transfer pricing planning protects value, ensures compliance and preserves flexibility across all potential approval scenarios.
KPMG Law LLP Ireland’s Life Sciences team provides an integrated framework to help companies structure early, prepare effectively and compete with confidence in the AI enabled and digitally evolving regulatory era.
