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Medicines and Healthcare products Regulatory Agency

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MHRA launches 2024/25 business plan with focus on enabling access to groundbreaking new technology while optimising delivery for all who need our services  

MHRA launches 2024/25 business plan with focus on enabling access to groundbreaking new technology while optimising delivery for all who need our services  

Monday, 07 October 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched its ambitious new business plan for 2024/25, setting out the agency’...

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MHRA approves first medicine for rare immune disease APDS

MHRA approves first medicine for rare immune disease APDS

Friday, 27 September 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has on 25 September approved leniolisib phosphate (Joenja) to treat a rare immune dise...

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MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox

MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox

Sunday, 22 September 2024

The MHRA, is calling for applications for manufacturers and developers of Artificial Intelligence (AI) medical devices, to join the AI Airlock regulat...

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Fruquintinib approved to treat adult patients with metastatic colorectal cancer ??

Fruquintinib approved to treat adult patients with metastatic colorectal cancer ??

Friday, 20 September 2024

?The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 20 September, approved the new medicine fruquintinib (Fruzaqla) to treat ad...

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Application route for performance studies under the In Vitro Diagnostics Regulations in Northern Ireland.

Application route for performance studies under the In Vitro Diagnostics Regulations in Northern Ireland.

Thursday, 19 September 2024

Submission and approval enabled of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland due to recent implement...

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MHRA launches new Strategy for Improving Safety Communications on World Patient Safety Day: Improving information to patients and healthcare professionals

MHRA launches new Strategy for Improving Safety Communications on World Patient Safety Day: Improving information to patients and healthcare professionals

Tuesday, 17 September 2024

New strategy aims to transform the way we provide information on the risks and safety of medicines and medical devices. ...

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MHRA advises men taking valproate and their partners to use effective contraception  

MHRA advises men taking valproate and their partners to use effective contraception  

Thursday, 05 September 2024

Men taking valproate and their partners are being advised by the Medicines and Healthcare products Regulatory Agency (MHRA) to use effective contracep...

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MHRA finds evidence does not support a link between Glucagon Like Peptide 1 (GLP 1) receptor agonists and suicidal and self injurious thoughts and actions

MHRA finds evidence does not support a link between Glucagon Like Peptide 1 (GLP 1) receptor agonists and suicidal and self injurious thoughts and actions

Tuesday, 03 September 2024

Following a thorough review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that the available evidence does not establi...

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Medicines and medical devices: Key back to school tips ??

Medicines and medical devices: Key back to school tips ??

Monday, 02 September 2024

As the new school year looms, the MHRA sets out key advice on children's medicines and medical devices. ...

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MHRA approves Spikevax JN.1 COVID 19 vaccines for adults and children from infancy

MHRA approves Spikevax JN.1 COVID 19 vaccines for adults and children from infancy

Sunday, 01 September 2024

The MHRA has approved an adapted Moderna COVID-19 vaccine (Spikevax) that targets the JN.1 COVID-19 subvariant....

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Appointments of four MHRA Non Executive Directors extended until 31 August 2025

Appointments of four MHRA Non Executive Directors extended until 31 August 2025

Thursday, 29 August 2024

Dr Junaid Bajwa, Professor Graham Cooke, Dr Paul Goldsmith and Rajakumari Long have had their appointments as Non-Executive Directors (NEDs) of th...

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Lecanemab licensed for adult patients in the early stages of Alzheimer’s disease

Lecanemab licensed for adult patients in the early stages of Alzheimer’s disease

Thursday, 22 August 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 22 August 2024, approved a product licence for the medicine lecanemab (Leqem...

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Zolbetuximab Approved to Treat Adults with Stomach or Gastro oesophageal Junction Cancer

Zolbetuximab Approved to Treat Adults with Stomach or Gastro oesophageal Junction Cancer

Wednesday, 14 August 2024

Zolbetuximab (Vyloy) is a monoclonal antibody that can recognise and attach itself to certain cancer cells to destroy them....

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Capivasertib approved to treat patients with advanced breast cancer

Capivasertib approved to treat patients with advanced breast cancer

Tuesday, 13 August 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine capivasertib (Truqap) for patients with ...

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Medicines and medical devices: Five top tips for summer?

Medicines and medical devices: Five top tips for summer?

Sunday, 28 July 2024

Key advice on medicines and medical devices for the holiday season....

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MHRA approves Comirnaty JN.1 COVID 19 vaccine for adults and children from infancy

MHRA approves Comirnaty JN.1 COVID 19 vaccine for adults and children from infancy

Tuesday, 23 July 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 24 July, approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) th...

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MHRA approves GLP –1 receptor agonist semaglutide to reduce risk of serious heart problems in obese or overweight adults

MHRA approves GLP –1 receptor agonist semaglutide to reduce risk of serious heart problems in obese or overweight adults

Tuesday, 23 July 2024

Semaglutide is the first weight loss drug approved in the UK as a preventative treatment for those with established cardiovascular disease...

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MHRA approves the first generic raltegravir medicines to treat adult and paediatric patients infected by HIV

MHRA approves the first generic raltegravir medicines to treat adult and paediatric patients infected by HIV

Friday, 19 July 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 19 July 2024, approved the first generic raltegravir medicines to treat adul...

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MHRA approves vibegron to treat adult patients with Overactive Bladder Syndrome (OAB)

MHRA approves vibegron to treat adult patients with Overactive Bladder Syndrome (OAB)

Wednesday, 17 July 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine vibegron (Obgemsa) to treat the sympto...

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Ocrelizumab approved as an injection to treat multiple sclerosis in adults

Ocrelizumab approved as an injection to treat multiple sclerosis in adults

Friday, 12 July 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new formulation of the medicine ocrelizumab (Ocrevus 920mg solution for ...

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Man who illegally imported unlicensed medicines from India, the Middle East and the Far East sentenced

Man who illegally imported unlicensed medicines from India, the Middle East and the Far East sentenced

Monday, 01 July 2024

A man who had unlicensed medicines sent to his parents’ address, has been sentenced at Southwark Crown Court to a term of imprisonment, having earlier...

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New pregnancy prevention measures introduced for topiramate 

New pregnancy prevention measures introduced for topiramate 

Thursday, 20 June 2024

Migraine and antiseizure medication topiramate must no longer be prescribed to women and girls unless they fulfil the requirements of a Pregnancy Prev...

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MHRA announces a proposed framework for international recognition of medical devices

MHRA announces a proposed framework for international recognition of medical devices

Tuesday, 21 May 2024

This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensure...

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MHRA announces consultation on improved safety for high risk in vitro diagnostic devices  

MHRA announces consultation on improved safety for high risk in vitro diagnostic devices  

Tuesday, 21 May 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) launched a four-week consultation which will support improved s...

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MHRA announces dedicated new team to support the international community in tackling antimicrobial resistance

MHRA announces dedicated new team to support the international community in tackling antimicrobial resistance

Thursday, 16 May 2024

Backed by a new award of £1.8 million, the Medicines and Healthcare products Regulatory Agency (MHRA) is to establish a dedicated team to provide regu...

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Pharmacists who illegally supplied more than 55 million doses of controlled drugs sentenced

Pharmacists who illegally supplied more than 55 million doses of controlled drugs sentenced

Thursday, 16 May 2024

Two pharmacists who sold ‘industrial’ quantities of Class C controlled drugs were yesterday sentenced to two years’ imprisonment each, suspended for 2...

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MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence

MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence

Thursday, 09 May 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 May 2024) launched AI Airlock, its new regulatory sandbox for AI as a Medi...

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Update on pioneering initiative on regulation and evaluation of digital mental health technologies

Update on pioneering initiative on regulation and evaluation of digital mental health technologies

Tuesday, 07 May 2024

An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs...

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New cabotegravir formulations approved to help prevent HIV 1 infection in adults and adolescents

New cabotegravir formulations approved to help prevent HIV 1 infection in adults and adolescents

Friday, 03 May 2024

The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months...

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MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030

MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030

Tuesday, 30 April 2024

The MHRA has today set out its strategic approach to artificial intelligence (AI)...

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