Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this roundup, you’ll find key publications that caught our attention, plus a curated summary of the most important regulatory news. Our goal is to highlight what matters, cut through the noise, and keep you up to date on changes that could impact drug development and market access in the UK, Europe and the US.
Regulatory Affairs News
New rules for critical medicines in the EU
The Critical medicines Act is a proposal for a new EU regulation to improve the availability, security and supply of essential medicines in the EU. Essential medicines include pain killers, antibiotics and insulin. The aim of the proposal is to make Europe’s healthcare system self-sufficient when faced with global health challenges that could threaten access to essential medicines.
The FDA launched TEMPO: The first digital health pilot to expand access to chronic disease technologies
The FDA launched the voluntary Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot to promote access to certain digital health devices while safeguarding patient safety. Led by the Center for Devices and Radiological Health, the pilot will test a risk-based enforcement approach for devices supporting cardio-kidney-metabolic, musculoskeletal and behavioural health conditions.
In collaboration with the Centre for Medicare and Medicaid Services Innovation Center ‘Advancing Chronic Care with Effective, Scalable Solutions (ACCESS)’ model, participating manufacturers will provide devices while collecting and reporting real-world performance data. Manufacturers may request enforcement discretion for certain regulatory requirements as evidence is generated. The pilot supports technology-enabled, integrated care and aligns with the rapid development of digital health.
TEMPO forms part of the FDA’s ‘Home as a Health Care Hub’ initiative and builds on experience from the Total Product Life Cycle Advisory Program. Statements of interest open in January 2026, with up to ten manufacturers selected per clinical area.
The MHRA opened a call for evidence on the ‘Regulation of AI in Healthcare’
The MHRA launched a ‘Call for Evidence’ to support the National Commission in the regulation of artificial intelligence (AI) in healthcare, led by the MHRA. The Commission brings together experts from healthcare, technology, law, patient groups, government and the National Health Service to address how AI medical devices should be regulated, with recommendations due in 2026.
AI offers potential to improve safety, efficiency and personalisation in healthcare, but also creates new regulatory challenges. The ‘Call for Evidence’ invites contributions from the UK and internationally to inform the Commission’s work, alongside planned public workshops. Input is particularly sought from patients, charities, industry, healthcare professionals, provider organisations and regulators.
Key topics include whether the current regulatory framework is sufficient, how it could be improved to enable faster access to safe and effective AI devices, how post-market safety should be monitored, and how responsibility and liability should be managed.
The MHRA approved tisotumab vedotin to treat cervical cancer
The MHRA approved tisotumab vedotin (Tivdak) under the International Recognition Procedure. It has been approved for the treatment of adults with cervical cancer that has come back or spread. It is used if the disease worsened after previous anti-cancer treatment.
Publications that caught our eye
- From the ESMO Congress 2025. Nature Reviews Clinical Oncology
- Cutting edge therapies: A review of Food and Drug Administration-approved drugs for non-small cell lung cancer. International Journal of Cancer
- Costs and benefits of early access to new cancer drugs through the US Food and Drug Administration’s accelerated approval pathway: retrospective observational study and economic evaluation. BMJ Medicine
- Medical Management of Obesity: A Comprehensive Review of Food and Drug Administration (FDA)-Approved and Investigational Therapies. Cureus
- Statistics in Medicine – What is an Estimand? The New England Journal of Medicine
- Navigating the Evolving Landscape of EGFR-Mutated NSCLC. The New England Journal of Medicine
- Cancer drug approvals and setbacks in 2025. Nature Cancer
- Are GLP-1 receptor agonists a ‘magic bullet’ for cancer? Nature Reviews Cancer
