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New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published.
These are the International Medical Device Regulatory Forum, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Medical Devices Innovation Consortium.
The UK regulator has taken safety action to reduce risks associated with Roche Accu-Chek Insight Insulin Pumps by issuing a national safety alert and outlining recommendations for patients.
It is the first treatment approved by the UK regulator that has been made possible through the Access Consortium ‘New Active Substance Work Sharing Initiative’.
The Medicines and Healthcare products Regulatory Agency is calling for women who experience symptoms associated with overactive bladder such as the urgent need to urinate to make their views heard as part of a consultation l…
Use of the Moderna COVID-19 vaccine or ‘Spikevax’ has been approved for 6 to 11s after meeting the required safety, quality and effectiveness standards
An approval has been granted after the Valneva COVID-19 vaccine was found to meet the required safety, quality and effectiveness standards.
Stakeholders and the UK public are invited to have their say on how the Medicines and Healthcare products Regulatory Agency (MHRA) manages the conflicts of interest for independent experts and how patients can be more involv…
The decision to grant approval for this treatment was endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after carefully reviewing the evidence.
The MHRA, NIHR, HRA and other organisations across the UK are working together to bring about changes which will drive up standards in health and social care research.
Syri Ltd has been fined £51,000 and ordered to pay costs of £104,898 by Aylesbury Crown Court.
A reflection by Dr June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency
The vaccine has been approved after meeting the required safety, quality and effectiveness standards.
The MHRA has launched a public consultation on a set of proposals to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies.
Significant clarification of the life-changing EAMS scheme to be introduced into law.
People are encouraged to contribute their views on far-reaching proposed revisions to the clinical trial legislation in the UK
A statement from Dame June Raine DBE on being recognised in the 2022 New Year Honours List
This new combination treatment is for people with mild to moderate COVID-19 who are at high risk of developing severe COVID-19
The Medicines and Healthcare products Regulatory Agency has today issued a recall asking patients to return affected products.
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, quality and effectiveness standards.
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