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The MHRA has launched a public consultation on a proposed Rare Disease Therapies Regulatory Framework, marking a significant shift in how therapies for very rare conditions will be developed and authorised in the UK.
In a tight funding market, the ability to generate early clinical data at speed can be an important driver of value.
Two recent developments in how the US and the UK work together in the life sciences sector promise significant improvements to trade, as well as greater access to innovative products for UK patients.
PMCPA has published revised and expanded guidance on the use of social media by pharmaceutical companies
The MHRA is currently consulting on access for CE marked medical devices to the market in Great Britain (England, Scotland, and Wales) over the longer term.
Two parallel schemes apply to control the costs of branded medicines to the NHS. These longstanding policy tools aim to ensure that the NHS can obtain the best possible value when purchasing medicines.
The MHRA has published an In Vitro Diagnostics Medical Devices Roadmap (IVDs Roadmap) as part of its wider Medical Devices Regulatory Reform Roadmap to implementation.
In an interesting development for the life sciences sector, and which could therefore also have significance for the health and education sectors, the government announced in late November 2025 that it was laying a statutory instrument to include Life Sciences infrastructure as key national infrastructure for the purposes of the Public Order Act 2023.
The government is moving to classify life sciences infrastructure as key national infrastructure under the Public Order Act 2023, a change that may also impact the health and education sectors.
The MHRA has launched its call for evidence on regulation of AI in healthcare. This particular call for evidence relates to AI used in medical devices (including standalone AI as a medical device).
Virtual wards and remote healthcare are reshaping the delivery of medical services. With the global telehealth market expected to reach $175.5 billion by 2026, both the UK and the EU are working to adapt their regulatory frameworks.
The recently announced US/UK trade deal on pharmaceuticals and medtech has been warmly welcomed by industry representatives, research institutes and medical research charities.