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Professor Anthony Harnden has officially commenced his role as chair of the Medicines and Healthcare products Regulatory Agency (MHRA). During his first 100 days, Professor Harnden plans to engage extensively with MHRA staff and partner organisations to gain a strong understanding of "how to drive forward the strategic direction of the MHRA to maintain the UK as a global centre of excellence in life sciences, in the best interests of patients and the public." The new MHRA chair has highlighted three primary areas of focus: Protect patient safety through robust safety surveillance systems Embrace risk-proportionate regulation Foster an inclusive workplace where people flourish. With a 40-year career in the NHS, including 33 years as a general practitioner in Wheatley, Oxfordshire, Professor Harnden brings a wealth of experience to the role. He is a professor of primary care at the University of Oxford. Until December 2024, he was also a registrant council member of the General Medical Council and chair of the Remuneration Committee.

The Medicines and Healthcare products Regulatory Agency (MHRA) has on Friday approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta syndrome or APDS in adults and adolescents aged 12-years-old and older who weigh 45kg or more. The medicine was approved via a fast-track approval process for medicines, known as the International Recognition Procedure (IRP), which allows the MHRA to consider the expertise and decision-making of trusted regulatory partners for the benefit of UK patients. The decision follows an approval for the drug by the US Food and Drug Administration (FDA). This is the first time the MHRA has approved a new medicine following FDA approval. The MHRA said it considered the assessment made by the US regulator as part of its own review, facilitating a rapid approval process. APDS is an inherited disorder where the patient is unable to fight infections because the immune system does not work properly. The main symptoms usually occur in the first two years of life and include repeated lung infections and a failure to grow and develop normally.

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new tool to check the eligibility for marketing authorisation applicants. Applicants are now required to use the online 'Eligibility Checker' tool to determine whether their Marketing Authorisation Application (MAA) is suitable for the Agency's International Recognition procedure (IRP), which will become operational on 1 January 2024. The tool will also help applicants identify which route (A or B) to follow, before submitting their IRP application. Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said that the tool has been tailored to "facilitate a smooth and efficient process for marketing authorisation applicants."

The Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed that Ozempic has been found at two UK wholesalers on 18 October. The pre-filled falsely labelled pens have been purchased from legitimate suppliers in Austria and Germany. However, there has been no evidence that fake Ozempic has been supplied to UK patients. Dr Alison Cave, MHRA Chief Safety Officer spoke about closely with regulatory partners to ensure patients' safety. He said: "Buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product either falsified or not licensed for use in the UK. "Products purchased in this way will not meet our strict quality and safety standards, and taking such medicines may put your health at risk," he added.

The Medicines and Healthcare products Regulatory Agency (MHRA) made its new International Recognition procedure (IRP) fully operational from 1 January 2024, inviting developers of new medicines to submit their applications for marketing authorisation. Beginning this year, the EC Decision Reliance Procedure (ECDRP) has been replaced by IRP, and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) has come under its umbrella. The move is expected to further improve access to life-saving medicines for UK patients following the UK's departure from the European Union.

The recent announcement that Royal Mail will be partnering with distance selling pharmacy (DSP) giant pharmacy2U highlights how standards of regulatory enforcement are being ignored to accommodate the DSP model. The brunt of these double standards hinges around the levelling down of temperature enforcement standards by the Medicines and Healthcare products Regulatory Agency (MHRA) which demands mapping must be audited from the point of dispensing to the patient. The MHRA has a well recognised duty to ensure medicines reach patients in a safe condition. The current anomaly appears to turn a blind eye to this step in the supply chain at the point the wholesaler releases goods to the pharmacy hub. Equally the training on delivering medicines safely and effectively direct to patients should apply fully to all hubs including DSPs. Why is it that DSPs are being treated differently to bricks and mortar pharmacies? It's essentially the same patients receiving the same medicines from the same wholesalers. A further regulatory disparity exists around how parcels must be "tracked and signed for" to be reasonably certain medicines are delivered into the hand of the intended recipient, as per existing regulations. Clearly an untracked, unsigned package cannot be guaranteed to finish in the hands of the intended recipient. There is a very real possibility that such omission could lead to community pharmacy closures which will, in turn, lead to unemployment and a reduction in the care services. At a time when integrated care systems have just gone live, the removal of vital support services leading to further inequalities is the wrong message for both providers and patients alike.