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Home » Topics » Regulatory » MHRA

MHRA
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Green checkmark and red X

UK nod for Alzheimer’s drug Kisunla, but NICE says no coverage

Oct. 23, 2024
By Nuala Moran

The U.K. Medicines and Healthcare products Agency has become the third to approve Eli Lilly and Co.’s Kisunla (donanemab), but the drug’s spending watchdog has simultaneously ruled the Alzheimer’s disease treatment is not cost effective.


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UK's MHRA eyes new regs for point-of-care drug manufacturing

Oct. 23, 2024
By Mark McCarty
The U.K.'s Medicines and Health Care Products Regulatory Agency (MHRA) has posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K. However, the agency has also floated a regulation for the production of pharmaceuticals at the point of care, a proposal MHRA said is the first of its kind.
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MHRA logo

UK MHRA posts series of stringent regulatory requirements

Oct. 22, 2024
By Mark McCarty
The U.K.'s Medicines and Health Care Products Regulatory Agency posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K.
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Man piecing together a puzzle

UK clears Leqembi for Alzheimer’s; NHS unlikely to embrace cost

Aug. 22, 2024
By Nuala Moran
The U.K. has become the first country in Europe to approve Leqembi (lecanemab), but as the breakthrough decision was announced, the health technology assessment body NICE said the benefits are too small to justify the cost of providing the Alzheimer’s disease therapy on the National Health Service (NHS).
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MHRA logo

UK MHRA launches AI airlock program for artificial intelligence

Aug. 21, 2024
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency enacted its AI Airlock program for artificial intelligence – the agency’s branding for its regulatory sandbox for this type of medical software.
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Illustration of DNA strand next to lungs
Respiratory

Intellia receives UK regulatory clearance for gene insertion therapy

July 31, 2024
Intellia Therapeutics Inc. has received clearance from the U.K. Medicine and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of NTLA-3001 for the treatment of α1-antitrypsin deficiency (AATD)-associated lung disease.
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Gastrointestinal

Resolution Therapeutics’ engineered macrophage cell therapy to enter clinic for decompensated liver cirrhosis

June 27, 2024
Resolution Therapeutics Ltd. has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of its lead candidate RTX-001 in patients with decompensated liver cirrhosis.
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Gears with regulatory words

Trio of regulators issues guidelines for transparency for AI

June 17, 2024
By Mark McCarty
For the third time in as many years, Health Canada, the U.S. FDA and the UK Medicines and Health Care Products Regulatory Agency have teamed up to issue a set of recommendations for artificial intelligence used in or as a medical device.
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Regulatory icons

MHRA considers mutual recognition policy for devices by 2025

May 23, 2024
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency is considering a policy of mutual recognition of medical devices that have won marketing authorization in four other jurisdictions, including the U.S. and the EU. While there are significant exclusions – such as for some articles that qualify as software as a medical device – this policy would be in force at some point in 2025, easing the path forward for products in a market that is home to nearly 67 million potential patients.
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Art concept for gene therapy research

UK MHRA expects to up-classify some AI device software

May 6, 2024
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) is among the regulators across the globe that are scrambling to keep pace with artificial intelligence (AI) in medical devices, releasing an April 30, 2024, paper on its own approach. One of the key considerations in this paper is that MHRA expects to up-classify some AI-enabled device software functions in its ongoing regulatory revamp, a prediction that suggests a more stringent premarket path for these products in the years ahead.
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