According to the UK's Medicines and Healthcare products Regulatory Agency and the Regulatory Innovation Office, a public call for evidence opened on 22 September 2026 soliciting stakeholder input on artificial intelligence applications for ADMET prediction and drug safety evaluation. The findings will directly inform a regulatory sandbox titled "Beyond ADMET: AI for medicines safety" and shape subsequent UK guidance documents. The mechanism operates as a controlled testing perimeter for novel methodologies, not as a finalized standard.
Submission scope and regulatory mechanism
The call targets AI-driven approaches to absorption, distribution, metabolism, excretion, and toxicity assessment, alongside downstream safety signal detection. The sandbox construct permits supervised deployment of new methods within a defined regulatory boundary prior to formal rulemaking. This is a procedural precedent with quantifiable downstream consequences for sponsors structuring nonclinical packages and for clinical investigators relying on legacy safety datasets.
Concurrent jurisdictional recalibration
On 21 September 2026, the U.S. Food and Drug Administration issued a direct final rule and companion proposed rule amending its nonclinical safety evaluation regulations. The action formally permits cell-based assays, computer modeling, and organs-on-chips where appropriate, substituting the term "nonclinical tests" for "animal tests" under the Food and Drug Omnibus Reform Act. The near-simultaneous sequencing of FDA and MHRA activity indicates coordinated movement across major regulatory blocs toward computational and in vitro alternatives, with a measurable variance in acceptable evidence thresholds for safety filings.
Operational thresholds to monitor
Three compliance variables warrant assessment. First, submission volume and provenance to the MHRA call, particularly the industry-to-academic ratio, will indicate sandbox design priorities and likely acceptance criteria for model qualification. Second, the FDA's companion proposed rule was issued alongside the direct final rule, establishing a parallel regulatory track that U.S.-bound sponsors must reconcile. Third, pharmacovigilance infrastructure is expanding in tandem: the African Medicines Agency has selected Qinecsa to deploy its HaloPV and QVW platforms for the AfriVigilance safety surveillance system, supported by the UK MHRA. The cumulative trajectory constitutes a documented shift in regulatory substrate. Sponsors persisting with animal-only ADMET dossiers will encounter incremental risk exposure as computational methods acquire formal standing, and mitigation strategies should begin now rather than at the point of guideline finalization.