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
The European Medicines Agency (EMA) created a podcast
The Inside EMA podcast offers a behind-the-scenes look at the EMA and the people involved in medicines regulation. Each episode explores how medicines are assessed before reaching patients, what is required to ensure they are safe and effective, and who the experts are behind key public health decisions in Europe. The podcast introduces listeners to the scientists, regulators and specialists working to ensure medicines for both people and animals in the European Union meet standards for safety, effectiveness and quality.
The FDA released a draft guidance on alternatives to animal testing in drug development
The FDA issued draft guidance to help drug developers validate new approach methodologies (NAMs) as alternatives to animal testing, supporting the use of human-centric data to bring safe, effective drugs to market sooner. The guidance outlines recommendations for submitting non-clinical NAMs data and reflects the FDA’s broader roadmap to reduce reliance on animal studies. Examples of NAMs include in vitro studies, organoids and organs-on-chips, computer simulations, chemical reactivity studies, and certain lower-animal models. These approaches can identify toxicities, demonstrate drug mechanisms, improve predictivity and enhance clinical trial safety. The draft guidance introduces four validation principles: context of use, human biological relevance, technical characterisation and fit-for-purpose. It provides general validation considerations and encourages developers to consult FDA review divisions when applying NAMs.
The FDA launched a new adverse event look-up tool
The FDA launched the FDA Adverse Event Monitoring System (AEMS), a unified platform for analysing adverse event reports across drugs, biologics, vaccines, cosmetics and animal food. The system provides a single dashboard, with plans to migrate historical data, retire legacy systems, and introduce enhanced application program interfaces and analytics tools. By May 2026, AEMS will contain real-time reports for all FDA-regulated products while protecting identifiable patient information. Previously, about 6 million reports were processed annually across seven databases, which were costly and difficult to search. AEMS is expected to improve transparency, reduce Freedom of Information Act requests, and save approximately $120 million over 5 years. Adverse event reports, submitted by patients, clinicians, consumers and manufacturers, support postmarketing surveillance by helping identify potential safety signals.
The FDA held a meeting with states on the importation of lower-cost drugs
The FDA met with several states to discuss the Section 804 Importation Program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to reduce costs for American consumers. The meeting supported the implementation of President Trump’s executive order on lowering drug prices and aimed to help interested states obtain authorisation while maintaining safety and quality. The FDA has invited states and tribes to submit draft SIP proposals for pre-review and receive feedback before formal submission, and is assisting with cost-savings analyses. In January 2026, the agency also launched a SIP quality assurance tool that provides tips, lessons learned and practical considerations to help sponsors prepare proposals aligned with regulatory requirements.
The MHRA published guidance on obtaining integrated scientific advice from the MHRA and NICE
The Integrated Scientific Advice service, delivered by the MHRA and the National Institute for Health and Care Excellence (NICE), provides pharmaceutical companies with coordinated guidance on regulatory and health technology assessment (HTA) evidence requirements through a single, streamlined process. Designed for products in clinical development, the service supports aligned pathway timelines and aims to enable earlier patient access to medicines. By clarifying evidence expectations early, companies can optimise development plans, avoid conflicting advice and reduce delays.
Key features include a single entry point, one combined advice report and a single payment route. Following a request, companies submit a briefing book, attend an integrated advice meeting with regulatory and HTA experts, and receive a unified written report with aligned recommendations. Advice may cover pivotal study design, real-world evidence generation and strategic planning. The service excludes joint advice for medical devices, with separate options available for regulatory-only or HTA-only guidance.
The MHRA paused the PATHWAYS clinical trial
The preliminary work for the PATHWAYS clinical trial investigating puberty blockers for children and young people with gender incongruence has been paused following new concerns raised by the MHRA. The pause means the trial will not begin recruiting participants while discussions take place between the regulator and the sponsor, King’s College London, to address the issues. The Department of Health and Social Care stated that the safety and well-being of participants and clinical evidence remain central considerations. Preparations for the trial are halted while clinicians review the evidence and resolve concerns, and the study will only proceed if expert scientific and clinical advice concludes it is safe and necessary.
The MHRA updated the guidance regarding what’s on offer in the Innovative Licensing and Access Pathway
The Innovative Licensing and Access Pathway (ILAP) offers developers a single integrated platform to collaborate with regulators, health technology assessment (HTA) bodies, the National Health Service (NHS) and patients to accelerate access to transformative medicines. The pathway provides joined-up, system-wide guidance from early clinical development, supporting a lifecycle approach that aligns regulatory, value and adoption requirements to reduce time to patient access. Core support for Innovation Passport holders includes development of a Target Development Profile and access to coordinated services, with optional tools recommended to maximise progress through development, licensing and uptake.
Recent updates to the refreshed ILAP emphasise selective entry, stronger NHS collaboration, and streamlined processes, alongside coordinated regulatory and HTA input to support faster, more predictable decision-making. The pathway enables early engagement, prioritised support services and alignment of evidence requirements to help innovative medicines reach patients more quickly.
Publications that caught our eye
- 3Rs at the European Medicines Agency: Past and future activities. NAM Journal.
- Age and frailty in anticancer drug regulatory assessment: a comprehensive cohort study of European marketing authorisations 2012-2023. ESMO Real World Data and Digital Oncology.
- Innovative oncology trial designs: Time to act – A review with recommendations of the Cancer Drug Development Forum. Journal of Cancer Policy.
- Novel drugs approved by the EMA, the FDA and the MHRA in 2025: A year in review. British Journal of Pharmacology.
- Review Duration and Therapeutic Value of Cancer Drugs Granted Priority Versus Nonpriority Review in the United States, European Union, and Switzerland (2010-2024). JCO Oncology Practice.
- RWE Submission for European Regulators and Payers: Challenges, Uncertainties and Opportunities. Therapeutic Innovation & Regulatory Science.
How Somerville Development Partners can help
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