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Last year, we considered NHS England's growing focus on AI scribes and the question that quickly became central to market access: when does an AI-enabled documentation tool become a regulated medical device?
The EU Pharma Package introduces changes to data and market protection, with new incentives for antimicrobials and repurposed medicines.
The High Court’s decision in Novo Nordisk v BT marks an important development in the use of website blocking injunctions, extending a well-established remedy into the health arena.
The 10 Year Health Plan for England and the Life Sciences Sector Plan commit to the NHS becoming the most AI-enabled healthcare system in the world, acknowledging the need for a modernised regulatory framework.
Medicines shortages are a persistent concern across Europe, affecting important categories of medicines including antibiotics, insulin, cancer treatments and vaccines.
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.