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Medicines and Healthcare products Regulatory Agency

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MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners

Friday, 26 May 2023

The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and ...

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New regulatory pathway set to support safe patient access to innovative medical technologies

New regulatory pathway set to support safe patient access to innovative medical technologies

Thursday, 25 May 2023

The Innovative Devices Access Pathway (IDAP), set for launch later in 2023, will be operated by the Medicines and Healthcare products Regulatory Agenc...

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Global AI challenge to investigate veterans’ cardiovascular health launched

Global AI challenge to investigate veterans’ cardiovascular health launched

Thursday, 25 May 2023

A brand-new challenge for artificial intelligence and machine learning developers, to build models that can predict heart failure-related health outco...

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MHRA and Genomics England to launch pioneering resource to better understand how genetic makeup influences the safety of medicines

MHRA and Genomics England to launch pioneering resource to better understand how genetic makeup influences the safety of medicines

Thursday, 25 May 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced it will be the first drug safety regulator in the world to pilot it...

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MHRA maintains prescription only status of Aquiette 2.5mg Tablets for symptoms of overactive bladder

MHRA maintains prescription only status of Aquiette 2.5mg Tablets for symptoms of overactive bladder

Thursday, 11 May 2023

Following a public consultation and the review of a reclassification application from the manufacturer, the MHRA has decided that Aquiette 2.5mg Table...

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Patients asked to return Emerade 300 and 500 microgram adrenaline pens for replacement

Patients asked to return Emerade 300 and 500 microgram adrenaline pens for replacement

Tuesday, 09 May 2023

Patients, or carers of patients, who carry Emerade 300 or 500 microgram adrenaline auto-injector pens should contact their GP and obtain a prescriptio...

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Moderna COVID 19 vaccine (Spikevax) authorised for use in infants and children aged 6 months to 5 years

Moderna COVID 19 vaccine (Spikevax) authorised for use in infants and children aged 6 months to 5 years

Tuesday, 09 May 2023

The COVID-19 vaccine from Moderna has met the MHRA’s required safety, quality and effectiveness standards to be authorised for use in this age group...

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Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU

Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU

Tuesday, 09 May 2023

The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of c...

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Medical devices – extended acceptance of CE marked medical devices on the Great Britain market

Medical devices – extended acceptance of CE marked medical devices on the Great Britain market

Friday, 28 April 2023

CE marked medical devices to be accepted in Great Britain for a longer period. ...

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Two Non Executive Directors reappointed to MHRA Board

Two Non Executive Directors reappointed to MHRA Board

Friday, 28 April 2023

The Department of Health and Social Care has today announced the reappointment of two Non-Executive Directors of the MHRA from 1 September....

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Outcome of the expert review of the safety of isotretinoin

Outcome of the expert review of the safety of isotretinoin

Wednesday, 26 April 2023

Following an expert safety review of isotretinoin, the Commission on Human Medicines has agreed to a number of recommendations to strengthen the safe ...

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MHRA Chair Stephen Lightfoot Standing Down

MHRA Chair Stephen Lightfoot Standing Down

Monday, 24 April 2023

After almost 8 years as a Board Member, Stephen has decided to step down on 11 July 2023. ...

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New MHRA cell therapy research evaluates immune stimulant cancer therapies to reduce side effects for patients

New MHRA cell therapy research evaluates immune stimulant cancer therapies to reduce side effects for patients

Thursday, 13 April 2023

Findings from research by the MHRA have been published, evaluating two different approaches to cancer therapies which harness the immune system to det...

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New statutory fees for MHRA services introduced from 1 April 2023

New statutory fees for MHRA services introduced from 1 April 2023

Saturday, 01 April 2023

Changes have been designed to ensure the agency is resourced to provide patients, the public and industry with the service they deserve and expect....

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Extension of CE certificates

Extension of CE certificates

Tuesday, 28 March 2023

The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR)....

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MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years

MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years

Tuesday, 21 March 2023

The legislative changes will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers. ...

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MHRA trialling pioneering stem cell robot that could transform the availability of life saving cell therapies

MHRA trialling pioneering stem cell robot that could transform the availability of life saving cell therapies

Thursday, 16 March 2023

The MHRA’s UK Stem Cell Bank is one of only two places in the world to test this technology....

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MHRA to receive £10m from HM Treasury to fast track patient access to cutting edge medical products

MHRA to receive £10m from HM Treasury to fast track patient access to cutting edge medical products

Wednesday, 15 March 2023

HM Treasury has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) will receive £10 million to help bring innovative new me...

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Safety withdrawal of pholcodine containing cough and cold medicines

Safety withdrawal of pholcodine containing cough and cold medicines

Tuesday, 14 March 2023

Following a comprehensive scientific safety review of the latest available data on the safety of pholcodine, together with advice from the independent...

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MHRA reclassifies Cialis Together tablets to a Pharmacy medicine

MHRA reclassifies Cialis Together tablets to a Pharmacy medicine

Tuesday, 14 March 2023

Following advice from the Commission on Human Medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified Cialis Togeth...

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UK members of international criminal gang sentenced to jail for involvement in the illegal sale and supply of prescription medicines valued at £3.7m

UK members of international criminal gang sentenced to jail for involvement in the illegal sale and supply of prescription medicines valued at £3.7m

Monday, 13 March 2023

Three members of an organised criminal gang were sentenced today (13 March 2023) at Stoke Crown Court to jail after pleading guilty to offences relati...

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Advisory Group Reform Proposals

Advisory Group Reform Proposals

Tuesday, 07 March 2023

Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform....

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MHRA safety review of medicines containing pseudoephedrine

MHRA safety review of medicines containing pseudoephedrine

Thursday, 23 February 2023

The MHRA is reviewing the evidence relating to the very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoc...

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Second bivalent COVID 19 booster vaccine from Moderna (Spikevax) authorised by UK medicines regulator

Second bivalent COVID 19 booster vaccine from Moderna (Spikevax) authorised by UK medicines regulator

Tuesday, 21 February 2023

This adapted COVID-19 vaccine targets both the original coronavirus (SARS-CoV-2) and the Omicron BA.4 and BA.5 sub-variants....

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UK to introduce first of its kind framework to make it easier to manufacture innovative medicines at the point of care

UK to introduce first of its kind framework to make it easier to manufacture innovative medicines at the point of care

Wednesday, 25 January 2023

The establishment of a regulatory framework for POC manufacturing would bring a range of benefits to patients, healthcare professionals and innovators...

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European Commission Decision Reliance Procedure (ECDRP) extension

European Commission Decision Reliance Procedure (ECDRP) extension

Tuesday, 24 January 2023

The ECDRP has been extended to 31 December 2023. From 1 January 2024, a new international recognition framework will be in place....

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MHRA increases UK assessment capacity for in vitro diagnostic devices

MHRA increases UK assessment capacity for in vitro diagnostic devices

Wednesday, 18 January 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that UL International UK Ltd is now designated to assess most in-vitro di...

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Professor Tom Clutton Brock MBE new Chair of the Interim Devices Working Group

Professor Tom Clutton Brock MBE new Chair of the Interim Devices Working Group

Monday, 16 January 2023

Professor Tom Clutton-Brock MBE has been appointed as Chair of the Medicines and Healthcare products Regulatory Agency’s (MHRA) Interim Devices Workin...

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Professor Sir Michael Rawlins

Professor Sir Michael Rawlins

Wednesday, 04 January 2023

Statement from Dr June Raine, MHRA Chief Executive, on Professor Sir Michael Rawlins...

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Sanofi Pasteur COVID 19 vaccine authorised by MHRA

Sanofi Pasteur COVID 19 vaccine authorised by MHRA

Wednesday, 21 December 2022

This new vaccine, VidPrevtyn Beta, has been authorised after meeting the MHRA’s required safety, quality and effectiveness standards....

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