t’s been said that geography is destiny. Should we accept this in medicine? Should the amazing advances in cancer therapy just be the sole property of those of us lucky enough to be born in wealthy countries? How do we get “precision medicine” to the millions worldwide who desperately need it?

So, what you need is sophisticated molecular diagnostic testing, advanced drug development pipelines, and wham!, a near-magical result that is the model for all cancer therapy. Of course, this all means little to the vast majority of cancer patients who live in areas without access to the diagnostics or medicines that make this near miracle possible.

egulators around the world are now reviewing hundreds of medical product submissions that embed artificial intelligence (AI) across the clinical‑development lifecycle, from automated protocol design, study conduct oversight, and real‑time safety monitoring to post‑market analytics. Yet many AI tools still fall short of the transparency and validation expected for regulated technologies.

n December 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the draft scientific guideline E22 on general considerations for patient preference studies for stakeholder review and feedback. It is widely acknowledged that input from patients, as users of medicines, can inform medicines development, enhance regulatory decision-making, and result in outcomes more relevant to patient interests. The draft ICH E22 Guideline is open for public consultation until April 12, 2026. It is now time to read, reflect upon, and respond to the proposed text.

oday, I am not here as a scientist or clinician; I am here as a parent. I am the mum of Lucía, a 10-year-old girl from Barcelona living with an ultrarare, degenerative condition with no approved treatment. And my experience has taught me something I want to say very clearly: Including children and families in the design of clinical trials is not a courtesy; it is a scientific, ethical, and human necessity.

series of global forums convened in recent months across Europe and Asia (see details at end of article) have surfaced a remarkably consistent signal about the future of patient engagement (PE) and patient experience data (PED): Regulators, patient organizations, and industry leaders across geographies and health systems are no longer debating whether PE and PED matter. The conversation has shifted decisively to how—and how quickly—they can be embedded into decision-making in a credible, systematic way.

osmetics have entered a new regulatory era. The US Modernization of Cosmetics Regulation Act of 2022 (MoCRA) created enforceable safety requirements with firm timelines, including serious adverse event reporting, safety substantiation, and facility registration and product listing. In the European Union (EU), Regulation (EC) No 1223/2009 continues to drive structured reporting of serious undesirable effects, while new environmental restrictions are accelerating reformulation. For many organizations, the pressure is practical: Teams must meet new regulatory clocks, improve data quality, and maintain consumer and regulator trust all at the same time.

he modern pharmaceutical industry supply chain is one of the most complex, delicate, and innovative supply chains to date. This series of interconnected activities involved in the sourcing, manufacturing, distribution, and delivery of pharmaceutical products to end users, including patients, healthcare providers, pharmacies, and hospitals, is designed to ensure patient access by directly enabling the availability and affordability of medicines, as well as the timely delivery of safe and effective medications. Recent geopolitical changes have caused significant rethinking of the supply chain from various industry and regulatory perspectives; many important investments and initiatives are underway to reach a new, more stable state.

he Identification of Medicinal Products (IDMP) standards establish a global framework for uniquely describing medicinal products consistently across jurisdictions. When widely and consistently used, IDMP enables reliable cross-border product identification, faster recall and shortage responses, improved pharmacovigilance, and efficient regulatory reliance.

he UK has recently introduced legislation to support Decentralised Manufacture (DM), which is an extension to the traditional methods of manufacturing a medicine in a central factory site that allows medicines to be manufactured close to the patient, potentially over a wide range of sites and facilities, where this is appropriate and delivers patient benefit. The DM designation creates flexible options under either modular manufacturing (MM) or Point of Care (POC); the latter is particularly useful for administering medicines with very short shelf life to patients.