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Medicines and Healthcare products Regulatory Agency

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World Cancer Day: How new partnerships are helping get breakthrough cancer medicines to patients sooner

World Cancer Day: How new partnerships are helping get breakthrough cancer medicines to patients sooner

Thursday, 10 February 2022

A reflection by Dr June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency ...

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Novavax COVID 19 vaccine Nuvaxovid approved by MHRA

Novavax COVID 19 vaccine Nuvaxovid approved by MHRA

Thursday, 03 February 2022

The vaccine has been approved after meeting the required safety, quality and effectiveness standards....

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Views sought on making first local vaginal HRT product available without need for prescription

Views sought on making first local vaginal HRT product available without need for prescription

Wednesday, 02 February 2022

The MHRA has launched a public consultation on a set of proposals to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies....

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UK’s Early Access to Medicines Scheme now to be put on a legal footing

UK’s Early Access to Medicines Scheme now to be put on a legal footing

Wednesday, 02 February 2022

Significant clarification of the life-changing EAMS scheme to be introduced into law. ...

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New proposals for the future of UK clinical trial legislation

New proposals for the future of UK clinical trial legislation

Monday, 17 January 2022

People are encouraged to contribute their views on far-reaching proposed revisions to the clinical trial legislation in the UK...

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New Years Honour for Medicines and Healthcare products Regulatory Agency Chief Executive

New Years Honour for Medicines and Healthcare products Regulatory Agency Chief Executive

Friday, 31 December 2021

A statement from Dame June Raine DBE on being recognised in the 2022 New Year Honours List...

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Oral COVID 19 antiviral, Paxlovid, approved by UK regulator

Oral COVID 19 antiviral, Paxlovid, approved by UK regulator

Friday, 31 December 2021

This new combination treatment is for people with mild to moderate COVID-19 who are at high risk of developing severe COVID-19...

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Strong steroid found in ‘natural’ skin cream

Strong steroid found in ‘natural’ skin cream

Thursday, 30 December 2021

The Medicines and Healthcare products Regulatory Agency has today issued a recall asking patients to return affected products. ...

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UK regulator approves use of Pfizer/BioNTech vaccine in 5 to 11 year olds

UK regulator approves use of Pfizer/BioNTech vaccine in 5 to 11 year olds

Wednesday, 22 December 2021

A new paediatric formulation of the Pfizer BioNTech COVID-19 vaccine has been approved for children aged 5 to 11 after meeting the required safety, qu...

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MHRA's new guidance on using real world data to support clinical trials could get medicines to patients sooner

MHRA's new guidance on using real world data to support clinical trials could get medicines to patients sooner

Thursday, 16 December 2021

This new guidance follows consultation with stakeholders from the pharmaceutical industry, academic research, trade associations, patient organisation...

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Temporary waiver of 15 minute observation period after COVID 19 mRNA vaccines

Temporary waiver of 15 minute observation period after COVID 19 mRNA vaccines

Tuesday, 14 December 2021

A statement on the temporary waiver of 15-minute observation period after COVID-19 mRNA vaccines ...

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MHRA approves Xevudy (sotrovimab), a COVID 19 treatment found to cut hospitalisation and death by 79%

MHRA approves Xevudy (sotrovimab), a COVID 19 treatment found to cut hospitalisation and death by 79%

Thursday, 02 December 2021

This monoclonal antibody – the second to be authorised by the Medicines and Healthcare products Regulatory Agency – is for people with mild to moderat...

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Precautionary recall of specific batches of blood pressure drug irbesartan

Precautionary recall of specific batches of blood pressure drug irbesartan

Tuesday, 30 November 2021

As a precaution, companies are recalling some batches of irbesartan medicines due to presence of a chemical substance (AZBT) in an amount over the lim...

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MHRA statement on expansion of the COVID 19 vaccination booster programme

MHRA statement on expansion of the COVID 19 vaccination booster programme

Monday, 29 November 2021

A statement from Dr June Raine on expansion of the COVID-19 vaccination booster programme....

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MHRA welcomes today’s announcement by the JCVI

MHRA welcomes today’s announcement by the JCVI

Monday, 15 November 2021

Our safety monitoring to date shows that COVID-19 vaccines continue to have a positive safety profile for the majority of people. ...

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Labelling error leads to retail level recall of cold and flu medicine

Labelling error leads to retail level recall of cold and flu medicine

Thursday, 11 November 2021

The labelling states an incorrect maximum daily dose for 12-15-year olds. The MHRA, who issued the recall, says that that the risk to patients is very...

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First oral antiviral for COVID 19, Lagevrio (molnupiravir), approved by MHRA

First oral antiviral for COVID 19, Lagevrio (molnupiravir), approved by MHRA

Thursday, 04 November 2021

The antiviral was found to be safe and effective following a stringent review of the available evidence. ...

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MHRA’s new Chief Healthcare Quality and Access Officer begins important role

MHRA’s new Chief Healthcare Quality and Access Officer begins important role

Wednesday, 03 November 2021

Dr Laura Squire OBE has begun her role as the Medicines and Healthcare products Regulatory Agency’s (MHRA) Chief Healthcare Quality and Access Officer...

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Every report counts: support the Yellow Card scheme by reporting suspected side effects

Every report counts: support the Yellow Card scheme by reporting suspected side effects

Monday, 01 November 2021

People who suspect they may have experienced a side effect from a medicine or vaccine are being encouraged to report it to the Medicines and Healthcar...

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MHRA publishes clear guidance to support bringing e cigarettes to market as licensed therapies

MHRA publishes clear guidance to support bringing e cigarettes to market as licensed therapies

Friday, 29 October 2021

The MHRA is committed to responding to the Tobacco Control Plan and supports the UK Government’s vision for a smoke-free generation by encouraging saf...

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UK, USA and Canadian regulators identify 10 guiding principles to be addressed when medical devices use AI or machine learning software

UK, USA and Canadian regulators identify 10 guiding principles to be addressed when medical devices use AI or machine learning software

Wednesday, 27 October 2021

These principles are intended to lay the foundation for developing good machine learning practices (GMLP) and will help guide future growth in this ra...

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MHRA launches public consultation on future of medical device regulation

MHRA launches public consultation on future of medical device regulation

Monday, 18 October 2021

People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK....

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Tesco Max All In One Chesty Cough & Cold Lemon Sachets are being recalled

Tesco Max All In One Chesty Cough & Cold Lemon Sachets are being recalled

Tuesday, 12 October 2021

Tesco Max All-In-One Chesty Cough & Cold Lemon Sachets used for the relief of cold and flu symptoms is being recalled...

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Innovative Licensing and Access Pathway (ILAP):  New partner announcement

Innovative Licensing and Access Pathway (ILAP): New partner announcement

Tuesday, 05 October 2021

AWTTC joins the Innovative Licensing and Access Pathway as a permanent partner...

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Transforming the regulation of software and artificial intelligence as a medical device

Transforming the regulation of software and artificial intelligence as a medical device

Thursday, 16 September 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) is updating regulations applying to software and artificial intelligence (AI) as a medi...

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Long term continual use of topical steroids linked to skin withdrawal side effects

Long term continual use of topical steroids linked to skin withdrawal side effects

Wednesday, 15 September 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) is advising anyone experiencing skin redness or burning sensations after they have stop...

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MHRA statement on COVID 19 booster vaccines

MHRA statement on COVID 19 booster vaccines

Tuesday, 14 September 2021

Regulatory updates by the MHRA today on the COVID-19 booster vaccine programme for winter 2021 to 2022...

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MHRA statement on booster doses of Pfizer and AstraZeneca COVID 19 vaccines

MHRA statement on booster doses of Pfizer and AstraZeneca COVID 19 vaccines

Thursday, 09 September 2021

The regulatory changes made by the MHRA today give further options for the deployment programme....

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Four Non Executive Directors appointed to the Medicines and Healthcare products Regulatory Agency Board

Four Non Executive Directors appointed to the Medicines and Healthcare products Regulatory Agency Board

Wednesday, 01 September 2021

Four Non-Executive Directors have been appointed to the board their terms come into effect from 1 September....

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Batch of metformin oral solution recalled by MHRA due to nitrosamine impurity

Batch of metformin oral solution recalled by MHRA due to nitrosamine impurity

Wednesday, 25 August 2021

Patients should not stop any treatments without consulting their doctor or pharmacist. ...

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