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Developers work with the NHS, the medicines regulator and the UK health technology assessment bodies from the early stages of clinical development, as part of the Innovative Licensing and Access Pathway.
The MHRA produces over 95 per cent of the World Health Organization’s (WHO) biological standards.
The MHRA’s Interim Executive Director of Science and Research writes in The British Medical Journal on the approval of the UK’s first new UTI antibiotic in nearly 30 years, and the wider challenge of tackling antibiotic resi…
Aligned pathway will streamline decisions on licensing and value for medicines, helping patients to benefit from them sooner.
Enhanced collaboration with the US on med tech regulation, with accelerated innovation, strengthened patient safety, and reduced transatlantic barriers to market access.
Patients receive earlier access to life-saving treatments as UK trial approval times cut in half from 91 to just 41 days.
The MHRA is inviting the next generation of doctors to explore how genetics could improve prescribing and patient safety in the UK.
The internationally renowned expert in the calculation and communication of risk and statistics, Sir David Spiegelhalter, discusses the concept of a ‘preference zone’ to frame the demands of safety, efficacy and choice in th…
People hospitalised following suspected use of unlicensed botulinum toxin products.
An updated joint Enforcement Notice provides important clarity on the kinds of claims and images in an ad that are likely to break the rules.
New National Commission unites clinical leaders, patient advocates and leading tech firms to make the NHS the most AI-enabled healthcare system in world
New Moderna Innovation and Technology Centre opened as government further boosts life sciences sector with £50 million fund.
Paracetamol should be taken as directed in the patient information leaflet
The importance of medicine safety and how to report side effects of medicines via the Yellow Card scheme is now part of the statutory guidance for schools in England.
As part of developing its new five-year strategy, the MHRA is publishing a series of blogs on the challenges and opportunities ahead. In the first instalment, Chief Executive Lawrence Tallon reflects on the changing healthca…
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 16th September 2025, approved the medicine vorasidenib (Voranigo).…
Patients implanted with affected devices should expect to be contacted directly for a follow-up assessment, if required.
As with any medicine, the MHRA will keep the safety of gepotidacin under close review.
As with any medicine, the MHRA will keep the safety of zuranolone under close review.
The pilot will help sponsors prepare for a new substantial modifications process under upcoming regulations, with responses delivered within 14 days.
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