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 Europe and the US.
News
Patients to receive medicines 3 to 6 months faster under the 10-year health plan
Under England’s 10-Year Health Plan, patients are set to receive new medicines 3–6 months faster. The National Institute for Health and Care Excellence and the MHRA will implement a joint information-sharing approach, allowing pharmaceutical companies to register early with both agencies and enabling parallel decision-making on licensing and value. This coordinated process ensures more medicines are approved for National Health Service use at the same time they are licensed in the UK.
The initiative forms part of the government’s industrial strategy and aims to reduce administrative costs for businesses by 25%. It provides an integrated advice service and an aligned pathway for medicine developers, streamlining both regulatory and Health Technology Assessment requirements, and clarifying the route to patient access. Companies can benefit by registering their products on UK PharmaScan at least 3 years before the expected marketing authorisation.
The MHRA was designated as a WHO listed regulatory authority
The MHRA has been designated as a WHO-Listed Authority (WLA), joining the world’s most trusted regulatory bodies alongside Health Canada and Japan’s Ministry of Health, Labour and Welfare (MHLW).
Pharmaceuticals and Medical Devices Agency (PMDA). This recognition affirms the MHRA’s commitment to the highest international standards in medical product regulation and strengthens the UK’s leadership in global health.
As part of a network of 39 WLAs, the designation supports faster, broader access to quality-assured medical products, particularly in low- and middle-income countries. It aligns with the UK Government’s Life Sciences Sector Plan and the 10-Year Health Plan, reinforcing ambitions to advance innovation, shift care to community settings, and improve patient access to safe and effective therapies.
The MHRA’s WLA status promotes regulatory convergence, reliance on trusted authorities and efficient resource use, marking a new era of global cooperation in regulation and enabling accelerated delivery of innovative medical products worldwide.
The MHRA approved teplizumab to delay type 1 diabetes progression
The MHRA approved teplizumab (Tzield) to delay the onset of Stage 3 type 1 diabetes (T1D) by an average of 3 years in adults and children aged 8 years and older with Stage 2 T1D. This marks the UK’s first-ever approved immunotherapy for type 1 diabetes. Stage 3 T1D is typically when blood sugar problems emerge, and lifelong insulin therapy is required. Teplizumab is administered to individuals in Stage 2 T1D, who are at high risk of progressing, providing a means to intervene earlier in the disease course. Approval was granted via the International Recognition Procedure, which allows the MHRA to leverage the expertise and decision-making of trusted regulatory partners. Teplizumab is administered as an intravenous infusion once daily for 14 days.
Publications that caught our eye...
Addressing global regulatory challenges in rare disease drug development. Drug Discovery Today
Real-World Data Included in Post-Authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024. Drug Discovery Today.
How to foster new treatment development in ultra-rare tumours? Joint EMA-EORTC multi-stakeholder workshops on ultra-rare sarcomas as a model for rare cancers. Cancer Treatment Reviews
