Drug regulation articles from across Nature Portfolio

Arega and Agunie analyze Ethiopia’s unregulated private antibiotic economy and propose a six-pillar framework of stewardship without walls to contain antimicrobial resistance in low-income settings.

Precise transgene regulation is crucial for the safety and efficacy of next-generation therapies. Here, authors develop RisdiON, a compact gene switch controlled by the approved oral drug risdiplam, showing this system allows for tunable, reversible regulation across diverse applications in vitro and in vivo.

The Australian Pharmaceutical Benefits Advisory Committee’s decision to allow tumour-agnostic reimbursement of nivolumab and ipilimumab is a bold experiment that involves a considerable level of risk-sharing between government, industry, clinicians and patients. The central policy challenge now is whether Australia has sufficient infrastructure and initiative to convert this access into timely and decision-relevant evidence. Reimbursement that accelerates access despite uncertainty carries an obligation to learn.

China’s integration of national reforms with institutional redesign has accelerated drug development and access to medicines. As momentum shifts globally, what can other nations learn from this experience?

The regulatory landscape for drug evaluation is shifting. For digital twins and in silico trials to become reliable evidence for drug approvals, these digital tools will require input from regulators and the public sector to ensure safe and responsible adoption.

Patent applications indicate a trend toward completely integrating artificial intelligence (AI) with drugs, whereby AI applications will be so tightly linked to drugs that the drugs could be effectively unusable without the AI.