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Medicines and Healthcare products Regulatory Agency

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MHRA warns of unsafe fake weight loss pens

MHRA warns of unsafe fake weight loss pens

Wednesday, 25 October 2023

Fake, potentially harmful Ozempic and Saxenda pens have been found in the UK: you should only access these medicines via a medical prescription. ...

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MHRA and international partners publish five guiding principles for machine learning enabled medical devices

MHRA and international partners publish five guiding principles for machine learning enabled medical devices

Tuesday, 24 October 2023

The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify ...

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MHRA authorises bispecific antibody therapy Tepkinly as a treatment for diffuse large B cell lymphoma in adults

MHRA authorises bispecific antibody therapy Tepkinly as a treatment for diffuse large B cell lymphoma in adults

Friday, 20 October 2023

Patients with recurring lymphoma, or who have not responded to prior treatments, could access a new bispecific antibody therapy to help treat their co...

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Falsified Ozempic (semaglutide) pens identified at two wholesalers in the UK

Falsified Ozempic (semaglutide) pens identified at two wholesalers in the UK

Tuesday, 17 October 2023

No evidence of supply or harm to patients ...

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New streamlined notification scheme for lowest risk clinical trials marks start of MHRA overhaul of regulation

New streamlined notification scheme for lowest risk clinical trials marks start of MHRA overhaul of regulation

Wednesday, 11 October 2023

The scheme will see the lowest-risk clinical trials processed by the MHRA in less than 14 days. ...

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Safety warnings to be provided to all patients with every valproate containing medicine they receive under new law

Safety warnings to be provided to all patients with every valproate containing medicine they receive under new law

Wednesday, 11 October 2023

Patients to receive the latest valproate safety information with every pack, following changes to the Human Medicines Regulations, 2012 ...

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Patients could have faster access to ground breaking stem cell treatment with manufacturing innovation

Patients could have faster access to ground breaking stem cell treatment with manufacturing innovation

Tuesday, 10 October 2023

Automation is the future for manufacturing stem cells, says the Head of the Medicines and Healthcare products Regulatory Agency’s UK Stem Cell Bank (U...

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SteriFeed colostrum collector not to be used to directly feed babies due to choking risk, MHRA advises

SteriFeed colostrum collector not to be used to directly feed babies due to choking risk, MHRA advises

Tuesday, 10 October 2023

Parents and carers should talk to their healthcare professional about how to feed colostrum (first milk) safely to their baby....

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MHRA pays tribute to Nobel Prize winning scientists behind mRNA COVID vaccines

MHRA pays tribute to Nobel Prize winning scientists behind mRNA COVID vaccines

Monday, 02 October 2023

Almost three years on from the approval in the UK of the first COVID-19 vaccine, the Medicines and Healthcare products Regulatory Agency (MHRA) pays t...

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MHRA authorises monoclonal antibody treatment, Jemperli, to be used with chemotherapy for endometrial cancer

MHRA authorises monoclonal antibody treatment, Jemperli, to be used with chemotherapy for endometrial cancer

Monday, 02 October 2023

For the first time, patients with certain types of advanced or recurrent endometrial cancer could access a treatment shown to slow its progression...

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UK patients set to have faster access to innovative medical technologies via new pathway

UK patients set to have faster access to innovative medical technologies via new pathway

Tuesday, 19 September 2023

The Innovative Devices Access Pathway (IDAP) pilot was launched today by the Department of Health and Social Care (DHSC), Health Technology Wales (HTW...

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MHRA approves Moderna’s adapted COVID 19 vaccine (Spikevax) that targets Omicron XBB.1.5

MHRA approves Moderna’s adapted COVID 19 vaccine (Spikevax) that targets Omicron XBB.1.5

Friday, 15 September 2023

The vaccine was approved after it was found to meet the MHRA’s standards of safety, quality and effectiveness....

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Berkshire couple receive prison sentence for illegal possession and supply of £1.6m of unlicensed medicines

Berkshire couple receive prison sentence for illegal possession and supply of £1.6m of unlicensed medicines

Friday, 08 September 2023

Karina Filimonova and Andrejs Stolarovs were each sentenced at Southwark Crown Court to eight months in prison for the illegal possession and intent t...

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MHRA approves Pfizer/BioNTech’s adapted COVID 19 vaccine (Comirnaty) that targets Omicron XBB.1.5

MHRA approves Pfizer/BioNTech’s adapted COVID 19 vaccine (Comirnaty) that targets Omicron XBB.1.5

Tuesday, 05 September 2023

The vaccine was approved after it was found to meet the UK regulator's standards of safety, quality and effectiveness...

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Guidance published on the new international regulatory recognition routes for medicines approvals

Guidance published on the new international regulatory recognition routes for medicines approvals

Monday, 04 September 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued detailed guidance on the new International Recognition Procedure (IRP) for m...

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Five people from Wolverhampton charged with illegal supply of prescription medicines and controlled drugs

Five people from Wolverhampton charged with illegal supply of prescription medicines and controlled drugs

Friday, 01 September 2023

An investigation by the Criminal Enforcement Unit (CEU) of the Medicines and Healthcare products Regulatory Agency (MHRA) has led to charges being bro...

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Three new UK Approved Bodies to certify medical devices announced by the MHRA

Three new UK Approved Bodies to certify medical devices announced by the MHRA

Tuesday, 29 August 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certi...

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Polio detection times could be halved using a scientific detection method, new research shows

Polio detection times could be halved using a scientific detection method, new research shows

Friday, 18 August 2023

New research supported by the Medicines and Healthcare products Regulatory Agency (MHRA) has shown that the time to detect polio can be halved using a...

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Safety of valproate – new study on risks in children of men taking valproate

Safety of valproate – new study on risks in children of men taking valproate

Wednesday, 16 August 2023

No action is currently needed from patients. No one should stop taking valproate without advice from their healthcare professional....

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MHRA reinforces anaphylaxis emergency guidance as hospital admissions rise

MHRA reinforces anaphylaxis emergency guidance as hospital admissions rise

Wednesday, 02 August 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has reinforced its safety guidance on the steps to take in anaphylaxis, after new figur...

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Bimervax COVID 19 vaccine authorised by MHRA

Bimervax COVID 19 vaccine authorised by MHRA

Tuesday, 01 August 2023

The new vaccine from HIPRA Human Health has been authorised after meeting the MHRA’s required safety, quality and effectiveness standards. ...

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MHRA launches public consultation on reclassification of opioid containing cough medicine

MHRA launches public consultation on reclassification of opioid containing cough medicine

Tuesday, 18 July 2023

Health professionals and the public have until 15 August to share their views on the potential reclassification of codeine linctus to a prescription-o...

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Thousands of unlicensed medical products seized in morning of raids in Bolton

Thousands of unlicensed medical products seized in morning of raids in Bolton

Thursday, 13 July 2023

The Medicines and Healthcare products Regulatory Agency’s (MHRA) Criminal Enforcement Unit (CEU) seized a quantity of suspected unlicensed medical pro...

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MHRA puts supporting patient access to innovation at the heart of its new Corporate Plan 2023 26

MHRA puts supporting patient access to innovation at the heart of its new Corporate Plan 2023 26

Tuesday, 04 July 2023

A new, visionary Corporate Plan, setting out how the Medicines and Healthcare products Regulatory Agency plans to keep patients safe by enabling acces...

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Timeframe for accepting CE marked medical devices in Great Britain extended

Timeframe for accepting CE marked medical devices in Great Britain extended

Friday, 30 June 2023

CE marked medical devices will continue to be accepted on the Great Britain market beyond 30 June 2023...

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Ban lifted on use of UK plasma to manufacture life saving albumin treatments

Ban lifted on use of UK plasma to manufacture life saving albumin treatments

Monday, 26 June 2023

Leading scientists at the independent Commission on Human Medicines (CHM) have confirmed that albumin, a critically important medicine for the NHS, ca...

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New lay commissioner appointed to the Commission on Human Medicines

New lay commissioner appointed to the Commission on Human Medicines

Monday, 19 June 2023

Mr David Crundwell joined the Commission on Human Medicines on 12 June 2023 as a lay representative....

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MHRA issues new guidance on the use of life saving adrenaline auto injectors

MHRA issues new guidance on the use of life saving adrenaline auto injectors

Monday, 19 June 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take du...

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Windsor Framework medicines announcement

Windsor Framework medicines announcement

Friday, 09 June 2023

New measures to commence 1 January 2025....

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West Midlands man sentenced to five years in prison for the illegal possession and intent to supply prescription medicines worth £2m

West Midlands man sentenced to five years in prison for the illegal possession and intent to supply prescription medicines worth £2m

Monday, 05 June 2023

Kieron Banks (34) was sentenced today at the Nightingale Court in Wolverhampton for the illegal possession and intent to supply prescription-only medi...

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