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Medicines and Healthcare products Regulatory Agency

782 articles

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MHRA’s new International Recognition Procedure (IRP) goes live from 1 January 2024

MHRA’s new International Recognition Procedure (IRP) goes live from 1 January 2024

Tuesday, 02 January 2024

In partnership with other global regulators, IRP is expected to further help bring life-saving new medicines to UK patients....

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Opdualag licensed for patients with advanced melanoma

Opdualag licensed for patients with advanced melanoma

Wednesday, 27 December 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (27 December) approved the advanced melanoma medicine Opdualag (nivolumab-rel...

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Medicines and medical devices: 5 top tips for the festive season

Medicines and medical devices: 5 top tips for the festive season

Thursday, 21 December 2023

From brussels sprouts to dodgy diet products, these tips from the MHRA will help you stay safe during the festive season and beyond ...

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Aripiprazole (Abilify): reminder on known risk of gambling disorder

Aripiprazole (Abilify): reminder on known risk of gambling disorder

Monday, 18 December 2023

The MHRA has reminded healthcare professionals prescribing aripiprazole to be alert to the known risk of patients developing addictive gambling, follo...

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Access Consortium Promise Pilot Pathway

Access Consortium Promise Pilot Pathway

Friday, 15 December 2023

New Access Work-Sharing Pathway for Priority Procedures....

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MHRA supports launch of Innovate UK’s first of its kind initiative to fund new Regulatory Science and Innovation Networks

MHRA supports launch of Innovate UK’s first of its kind initiative to fund new Regulatory Science and Innovation Networks

Thursday, 14 December 2023

Applications are now open for academic institutions wishing to bid for funding to collaborate with others to establish new Regulatory Science and Inno...

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Manchester family locked up for illegal sale and supply of unlicensed medicines worth £1.5m

Manchester family locked up for illegal sale and supply of unlicensed medicines worth £1.5m

Monday, 11 December 2023

Three men have been sentenced to a total of three years at Manchester Crown Court after pleading guilty to the illegal sale and supply online of presc...

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Precautionary action taken to amend incorrect expiry dates of flu nasal spray vaccines

Precautionary action taken to amend incorrect expiry dates of flu nasal spray vaccines

Thursday, 30 November 2023

Patients can be reassured that Fluenz nasal spray vaccines remain safe and effective when used within the revised expiry dates....

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Thousands of illicit medicines seized in morning of raids in Manchester

Thousands of illicit medicines seized in morning of raids in Manchester

Wednesday, 29 November 2023

The Medicines and Healthcare products Regulatory Agency’s (MHRA) Criminal Enforcement Unit (CEU) seized hundreds of thousands of doses of suspected il...

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MHRA instructs health organisations to prepare now for new measures to reduce ongoing serious harms of valproate

MHRA instructs health organisations to prepare now for new measures to reduce ongoing serious harms of valproate

Tuesday, 28 November 2023

Other effective medicines are available for epilepsy and bipolar disorder and valproate should only be used if these don’t work or aren’t suitable for...

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Specific batches of carbomer containing lubricating eye gels branded Aacarb, Aacomer and Puroptics recalled as a precaution due to possible microbial contamination

Specific batches of carbomer containing lubricating eye gels branded Aacarb, Aacomer and Puroptics recalled as a precaution due to possible microbial contamination

Friday, 24 November 2023

MHRA tells patients and healthcare professionals to stop using affected gels and retailers told to withdraw affected products....

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MHRA launches online Eligibility Checker tool for applications via the new  International Recognition Procedure (IRP)

MHRA launches online Eligibility Checker tool for applications via the new  International Recognition Procedure (IRP)

Monday, 20 November 2023

IRP is expected to further help bringing life-saving new medicines to UK patients from 1 January 2024...

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MHRA authorises world first gene therapy that aims to cure sickle cell disease and transfusion dependent ? thalassemia

MHRA authorises world first gene therapy that aims to cure sickle cell disease and transfusion dependent ? thalassemia

Thursday, 16 November 2023

Casgevy (exagamglogene autotemcel) is based on the innovative gene-editing tool CRISPR, which won its inventors the Nobel Prize in 2020...

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Cystic fibrosis drugs Kaftrio and Kalydeco licensed for patients aged two to five years old

Cystic fibrosis drugs Kaftrio and Kalydeco licensed for patients aged two to five years old

Wednesday, 15 November 2023

For the first time, 2- to 5-year-old patients with a certain type of cystic fibrosis could access cystic fibrosis drugs Kaftrio and Kalydeco....

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MHRA joins global regulatory partners in celebrating ten years of international medicines regulatory cooperation

MHRA joins global regulatory partners in celebrating ten years of international medicines regulatory cooperation

Thursday, 09 November 2023

As a founding member and former chair of the?International Coalition of Medicines Regulatory Authorities (ICMRA), the Medicines and Healthcare product...

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MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss

MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss

Wednesday, 08 November 2023

For the first time in the UK, obese patients and people who are overweight with weight-related health problems could now have access to Mounjaro, curr...

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MHRA authorises enzyme inhibitor Anastrozole to prevent breast cancer in post menopausal women

MHRA authorises enzyme inhibitor Anastrozole to prevent breast cancer in post menopausal women

Monday, 06 November 2023

Anastrozole is now authorised as a preventative treatment for post-menopausal women at moderate or high risk of breast cancer....

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Suspect you have experienced a side effect or incident from a healthcare product? Submit a Yellow Card report to improve safety for everyone

Suspect you have experienced a side effect or incident from a healthcare product? Submit a Yellow Card report to improve safety for everyone

Monday, 06 November 2023

Whether you’re a patient, healthcare professional or carer, this year’s #MedSafetyWeek campaign is calling on you to help improve the safety of medica...

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MHRA authorises Krazati as a treatment for non small cell lung cancer in adults

MHRA authorises Krazati as a treatment for non small cell lung cancer in adults

Friday, 03 November 2023

Patients with a certain type of advanced or spreading non-small cell lung cancer (NSCLC) could access a new cancer therapy to help treat their conditi...

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MHRA authorises Litfulo as a treatment for severe alopecia areata in adults and adolescents 12 years and older

MHRA authorises Litfulo as a treatment for severe alopecia areata in adults and adolescents 12 years and older

Wednesday, 01 November 2023

Patients with severe alopecia areata (patchy hair loss) could access a new medicine to help treat their condition....

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15 years of Op Pangea: over 25 million illegally traded medicines and devices seized in the UK valued at more than £84m

15 years of Op Pangea: over 25 million illegally traded medicines and devices seized in the UK valued at more than £84m

Tuesday, 31 October 2023

Over two million doses of illegally traded medicines valued at almost £5m seized so far this year....

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Treatment with isotretinoin for patients under 18 must be approved by two prescribers, under new MHRA rules

Treatment with isotretinoin for patients under 18 must be approved by two prescribers, under new MHRA rules

Tuesday, 31 October 2023

New measures strengthen the safe use of the acne drug isotretinoin for patients across the UK, following a patient-focused expert review...

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MHRA to launch the AI Airlock, a new regulatory sandbox for AI developers

MHRA to launch the AI Airlock, a new regulatory sandbox for AI developers

Monday, 30 October 2023

The AI-Airlock will assist in the development and deployment of software and AI medical devices, safely providing patients with earlier access to cutt...

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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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