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 EMA consults on virtual groups to help reduce animal use in medicines development
The EMA issued a draft qualification opinion for a new preclinical methodology using virtual control groups to reduce animal use (rats) in dose-range finding studies. This approach replaces standard animal control groups with statistically derived ‘virtual comparator animals’, supported by expert judgement. If qualified, evidence generated using this method will be accepted as scientifically valid in future medicines applications within a defined context.
This marks the first qualification of a new approach methodology in toxicity assessment and provides a blueprint for broader adoption in studies where control groups are required. The initiative supports the 3Rs principles—replace, reduce and refine animal use—and aligns with international efforts to reduce reliance on animal testing. The EMA emphasises that implementation must not compromise study outcomes or human safety, while also aiming to improve the relevance and predictability of non-clinical testing.
The FDA announced major steps to implement real-time clinical trials
The FDA announced two key steps to advance real-time clinical trials (RTCTs). The agency unveiled the successful initiation of two proof-of-concept clinical trials that will report endpoints and data signals to the agency in real time. Second, the agency released a Request for Information (RFI) regarding a proposed pilot programme for RTCT that will launch this summer. The two proof-of-concept trials, led by AstraZeneca and Amgen, were designed to report clinical endpoints and safety signals in real time, demonstrating the feasibility of this approach. The RTCTs aim to address inefficiencies in early-phase development, where data is traditionally analysed and submitted after collection. Leveraging artificial intelligence and data science, real-time trials hop to enable continuous data sharing, improving safety monitoring and decision-making.
The FDA reminded more than 2,200 sponsors and researchers to disclose trial results
The FDA reminded over 2200 companies and researchers to comply with requirements to submit clinical trial results to ClinicalTrials.gov. Failure to report—particularly negative results—creates publication bias, distorts perceptions of safety and efficacy, and leaves gaps in the public record.
An internal analysis found that 29.6% of studies likely subject to mandatory reporting requirements had not submitted results. These requirements apply to certain interventional studies involving FDA-regulated products, with results due 1 year after completion.
On March 30, 2026, the FDA contacted organisations linked to more than 3000 trials to encourage voluntary compliance or completion of quality control review. This outreach forms part of broader risk-based compliance efforts, with potential escalation to formal non-compliance notices if requirements are not met.
The FDA issued draft guidance on genome editing safety standards to advance gene therapy development
The FDA issued draft guidance on the safety assessment of genome editing in human gene therapy products. Developed by the CBER, the guidance outlines recommendations for using next-generation sequencing to evaluate risks such as off-target editing and loss of genome integrity.
It provides direction on sequencing strategies, sample selection, analysis parameters, and reporting to support nonclinical studies submitted in investigational new drug and biologics license applications. The guidance applies to both ex vivo and in vivo gene editing approaches.
This initiative supports the FDA’s broader framework to accelerate the development of therapies for ultra-rare diseases. Sponsors are encouraged to engage early with the agency, including through INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products) and pre-Investigational New Drug meetings, to align on development strategies and safety assessment approaches.
The FDA is taking steps forward on testosterone therapy for men
The FDA has encouraged sponsors of approved testosterone replacement therapy (TRT) products to explore a potential new indication for treating low libido in men with idiopathic hypogonadism. Currently, TRT is approved only for men with hypogonadism linked to known structural or genetic causes.
Following a review of emerging clinical evidence and discussions at a December 2025 expert panel, the FDA identified data suggesting TRT may be safe and effective for men with low testosterone levels without a known cause. The assessment was based on well-controlled clinical trials evaluating relevant outcomes.
The agency is now inviting holders of approved new drug applications to engage and consider submitting a supplemental application, including the necessary data to support approval for this potential new indication.
The FDA achieved its 1-year goals in reducing animal testing in drug development
The FDA reported progress on its 2025 roadmap to reduce animal testing in preclinical safety studies, marking a year of advancing human-relevant approaches to drug development. Recognising the limitations of animal models—where over 90% of drugs fail in human trials—the FDA is promoting new approach methodologies, including in vitro systems, computational modelling and human-derived platforms.
Since launching the roadmap, the agency has issued draft guidance to reduce non-human primate testing, supported alternatives to horseshoe crab endotoxin testing, expanded weight-of-evidence approaches, and qualified its first artificial intelligence-based drug development tool. It has also introduced a database on acceptable alternatives and strengthened international collaboration.
With new infrastructure and partnerships, including with the National Institutes of Health, the FDA aims to improve safety prediction, accelerate development, reduce costs and expand patient access, while significantly reducing reliance on animal testing.
The MHRA approved Enflonsia to prevent RSV in newborns and infants
The MHRA approved Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants up to 12 months during their first RSV season.
RSV is a common and highly contagious illness that can lead to serious conditions such as pneumonia and bronchiolitis, particularly in young children.
Enflonsia contains clesrovimab, an antibody designed to help prevent RSV-related lung disease by supporting the body’s immune response. The treatment is administered as a single injection by a healthcare professional.
The most common side effects reported include pain, swelling, redness or rash at the injection site.
The MHRA is introducing the largest clinical trials reform package in 20 years
The MHRA and Health Research Authority (HRA) are introducing the most significant clinical trial reforms in over 20 years, aimed at accelerating study start-up while maintaining high safety standards.
Key changes include faster assessment of first-in-human trials, a new fast-track route for lower-risk studies, and the introduction of notifiable trials. The reforms also support innovative approaches, such as using overseas safety data and computer modelling.
Recent improvements have already reduced trial set-up times from 169 to 122 days, with combined reviews averaging 41 days. The new Route B pathway enables rapid approval of certain modifications—averaging 7 days during the pilot—and will be mandated from April 2026.
These changes aim to simplify trial processes, improve transparency, and enable faster access to clinical research for patients and investigators.
The MHRA is hosting a live ‘ask me anything’ on how AI is being regulated in healthcare
The MHRA is hosting a live Ask Me Anything session on how artificial intelligence (AI) is being regulated in healthcare, offering the public an opportunity to engage directly with the National AI Commission.
The session will cover the Commission’s work, how regulatory decisions are made and what AI could mean for patient care, with open discussion on topics such as patient safety and responsible use.
AI has the potential to improve healthcare by enabling earlier diagnosis, supporting clinicians and enhancing care delivery, but also raises important questions around safe and ethical implementation.
The Commission brings together experts across healthcare, science, technology and policy to develop recommendations that protect patients, support innovation and guide future regulation. Public input—gathered through consultations, workshops and research—is central to shaping this work and future regulatory frameworks.
Publications that caught our eye
- Dose selection of novel anticancer drugs: exposing the gap between selected and required doses. The Lancet Oncology
- Unlocking the potential of disease prevention through regulatory science. Nature Reviews Drug Discovery.
- 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 and regulatory science.
- Rare Cancers Bill to become law in the UK. The Lancet Oncology
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