Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
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Dr Nicola Rose: A new antibiotic is positive news – but it will take more to stay ahead of superbugs
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 resistance.
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The MHRA invite feedback on the use of designated standards for medical devices and in vitro diagnostic (IVD) devices to help shape future initiatives.
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MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.