MHRA

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MHRA

 •  January 30

HIW is the independent inspectorate and regulator of healthcare in Wales. They also monitor the use of the Mental Health Act 1983 and 2007, and the Mental Health (Wales) Measure 2010, and protect the interests of people whose rights are restricted under this legislation. Our working relationship helps maintain an effective regulatory system for...

MHRA

 •  January 16

The European Council formally agreed on 15 December that sufficient progress has been made to move on to the second stage of the negotiations, and adopted guidelines for that second phase. This followed the publication of a Joint Report on progress during the first phase by the Government and the European Commission on 8 December. These are...

MHRA

 •  October 23, 2017

MHRA is releasing the response to January’s consultation on the strategy for pharmacopoeial public quality standards for biological medicines In January 2017, MHRA launched a public consultation on pharmacopoeial quality standards for biological medicines. The quality of biological medicines, which are an increasingly important part of healthcare...

MHRA

 •  October 10, 2017

For science, research, and innovation to provide solutions to global health challenges, people and ideas need to be able to come together to make a difference, Dr Jeremy Farrar OBE, Director of the Wellcome Trust said at the 12th Annual Lecture organised by the Medicines and Healthcare products Regulatory Agency in London tonight, 10 October...

MHRA

 •  September 20, 2017

The UK BioIndustry Association (BIA) and the Medicines and Healthcare products Regulatory Agency (MHRA) brought together experts from across the sector to discuss some hot topics and important developments that are having an impact on the changing and dynamic UK life sciences ecosystem. Through a series of presentations, panel discussions and Q and...

MHRA

 •  September 19, 2017

In collaboration with key stakeholders, MHRA has produced guidance on the human factors aspects of design for medical devices including those in drug-device combination products. This guidance is intended for manufacturers, developers and notified bodies to highlight the important influence human factors have on patient safety. The advice is also...

MHRA

 •  September 18, 2017

The Medicines and Healthcare products Regulatory Agency is conducting a survey to better understand how it can support its customers As part of our continued commitment to deliver a high-quality service to our customers, stakeholders and partners, the Medicines and Healthcare products Regulatory Agency is embarking on a major operational...

MHRA

 •  August 29, 2017

From sticking plasters to hip replacements, contact lenses to implanted pacemakers, medical devices are a part of everyday life. To make sure these medical devices are acceptably safe and perform as intended, they must comply with the relevant EU legislation. The Medicines and Healthcare products Regulatory Agency (MHRA) has created an introductory...

MHRA

 •  August 24, 2017

People with diabetes who use NovoPen® Echo® and NovoPen® 5 should check to see if their devices are included in the company-led recall by Novo Nordisk. The insulin cartridge holder in certain batches may crack or break resulting in an under-delivery of insulin which can lead to high blood glucose (hyperglycaemia) and can have serious health...

MHRA

 •  August 22, 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) is warning people to not use or buy Hightop HIV/AIDS Home Test Kit after seizing 114 potentially unreliable products from 2 UK based suppliers. If you believe you have used a Hightop HIV/AIDS Home Test Kit you should seek a further HIV test at your local sexual health clinic or through...