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The MHRA has today launched a public consultation on the revised ICH guideline on Good Clinical Practice.
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners
The Innovative Devices Access Pathway (IDAP), set for launch later in 2023, will be operated by the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), He…
A brand-new challenge for artificial intelligence and machine learning developers, to build models that can predict heart failure-related health outcomes for veterans has been launched by a collaboration between regulators a…
The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced it will be the first drug safety regulator in the world to pilot its own genetic ‘biobank’, launching 1 June 2023
A serious shortage protocol (SSP) has been issued across the UK for Utrogestan® 100mg capsules today (19 May 2023).
First published during the 2022 to 2024 Sunak Conservative government
Following a public consultation and the review of a reclassification application from the manufacturer, the MHRA has decided that Aquiette 2.5mg Tablets will remain a prescription-only medicine.
Patients, or carers of patients, who carry Emerade 300 or 500 microgram adrenaline auto-injector pens should contact their GP and obtain a prescription for, and be supplied with an alternative brand. They should then return …
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 certain device certificates
The government, NHS England and the pharmaceutical industry will begin negotiating the successor to the voluntary scheme for branded medicines, pricing and access (VPAS).
CE marked medical devices to be accepted in Great Britain for a longer period.
The Department of Health and Social Care has today announced the reappointment of two Non-Executive Directors of the MHRA from 1 September.
Health and Social Care Secretary Steve Barclay delivered a speech to the Association of the British Pharmaceutical Industry (ABPI) annual conference.
Following an expert safety review of isotretinoin, the Commission on Human Medicines has agreed to a number of recommendations to strengthen the safe use of the treatment.
After almost 8 years as a Board Member, Stephen has decided to step down on 11 July 2023.
Voluntary scheme for branded medicines pricing and access (VPAS) delivers value for money to taxpayer and saves NHS billions, facilitating patient access to new lifesaving treatments and medicines, and supporting UK life sci…
Findings from research by the MHRA have been published, evaluating two different approaches to cancer therapies which harness the immune system to determine which better targets cancer cells and would reduce side effects for…
Guidance in relation to Regulation 238 of the Human Medicines Regulations 2012
37,700 women have purchased hormone replacement therapy (HRT) prescription prepayment certificates (PPC) following the launch, saving over £1.13 million.
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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