Group items tagged

Medicines and Healthcare products Regulatory Agency (MHRA) has urged the healthcare professionals to share their views on the consultation on 'how MHRA communicate with healthcare professionals to improve medicines and medical devices' safety'. Through this consultation the agency wants to review its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. "We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients," said MHRA. "We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we work together on our common goal of greater patient safety."

In a recent announcement the Medicines and Healthcare products Regulatory Agency (MHRA) unveiled its strategic approach to artificial intelligence (AI), as it sets out to embrace the transformative potential of AI in healthcare regulation. Building upon the Government's white paper 'A pro-innovation approach to AI regulation', released in 2023, the MHRA outlined five key strategic principles guiding its adoption of AI. These principles encompass safety, security, and robustness; appropriate transparency and explainability; fairness, accountability, and governance; and contestability and redress. A science-led organization, the MHRA was tasked with providing an independent view of its approach to AI in medicine and science, aligning with a government white paper. Recognising its role in UK's goal to be a science and tech leader by 2030, MHRA is tasked to evaluate AI's opportunities and risks across regulatory, public service, and evidence-based decision-making area.

The Medicines and Healthcare products Regulatory Agency's (MHRA) Criminal Enforcement Unit (CEU) has seized a quantity of suspected unlicensed medical products including unlicensed versions of Botox, numbing agents and dermal fillers in Bolton, Greater Manchester. Officers from the MHRA and Greater Manchester Police conducted a raid across nine addresses in Bolton, Westhoughton and Leigh in the early hours of Thursday 13 July 2023, where two women and a man were arrested. Andy Morling, MHRA Deputy Director of Criminal Enforcement said: "Medicines like these are powerful and dangerous in the wrong hands, potentially leading to serious adverse health consequences. The criminals trading in these products are not only breaking the law, they also have no regard for your safety. It is illegal to advertise, sell or supply medicines such as these without the appropriate authorisation. If you see these products, or any other powerful medicines, being sold on social media or elsewhere online, think. It's unlikely to be legitimate. You can help the MHRA take action by reporting concerns to us through our Yellow Card scheme.

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 Medicine and Healthcare Product Regulatory Agency (MHRA) has recalled all pholcodine-containing medicines from the UK pharmacy due to concerns of its potential to cause a severe allergic reaction in some people having general anaesthesia for surgery. The decision was made following the conclusion of a review of post-marketing safety data by the MHRA. The Commission on Human Medicines (CHM) has considered the evidence of an increased risk of the very rare event of anaphylaxis when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing medicines should be withdrawn. MHRA has advised pharmacists to consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine. Royal Pharmaceutical Society (RPS) President Professor Claire Anderson said: "If you are taking a cough medicine (including tablets and syrups), check the packaging, label or Patient Information Leaflet to see if pholcodine is a listed ingredient - if it is, and you have any questions, you can talk to your pharmacist who can suggest a different medicine suitable for you.

Britain's drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced that fluoroquinolone antibiotics must only be administered when no other antibiotics are appropriate for use. It elaborated that fluoroquinolones given systemically (by mouth, injection, or inhalation) should only be prescribed "when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient." Previous regulations on fluoroquinolones stated that this class of antibiotics should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions. Further restrictions have been introduced after receiving reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, the MHRA revealed. Dr Alison Cave, MHRA Chief Safety Officer, said: "Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections.

The Medicines & Healthcare products Regulatory Agency has initiated a recall of three batches of Quantum Pharmaceutical's Diltiazem HCl 2% Cream, which is an unlicensed medicine. MHRA issued a precautionary recall of the cream due to a change in the product's appearance that affected its thickness. Pharmacists are instructed to halt supply, quarantine remaining stock, and contact Quantum Pharmaceutical to return affected batches M1402497, M1402574, and M1402680. Patients using this product may encounter application issues with the cream due to its consistency. However, MHRA said that this has not impacted the product's effectiveness or posed any risk to patient safety. The MHRA also reported that medac GmbH (t/a medac Pharma LLP) is conducting a recall of two batches of Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) with batch numbers G220393B and G220393C. This class 2 medicines recall is a result of particles detected during long-term stability tests.

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK. Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in  the UK Medical Devices Regulations 2002. Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market. Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

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 been accepted as a full member of three international work-sharing partnerships. Through these partnerships the agency said it will play vital international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, Two of these, the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are focused on improving the harmonisation and convergence of medicines and medical devices regulation globally. The partnerships will also help the MHRA to share expertise with other leading organisations, support the development of regulatory guidelines and drive greater harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised 'no one should stop taking valproate without advice from their healthcare professional.' The latest data on the use of valproate in England revealed that in the last 6 months the number of pregnant women prescribed valproate in a 6-month period has fallen from 68 women in April to September 2018, to 17 women in October 2021 to March 2022. In light of concerns that the current regulatory requirements for safe use are not being consistently followed, the MHRA conducted a review of the available data and asked for advice from the independent Commission on Human Medicines (CHM). "The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment," said MHRA. "Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply."

People are advised to be mindful of medications that may cause sun reactions, and to watch out for dodgy hay fever treatments and fake weight loss pens. For those traveling abroad, the MHRA advises considering the suitability of medicines available to reduce the risk of contracting tropical diseases. Dr Alison Cave, Chief Safety Officer at the MHRA, said: "The summer is an exciting time for many of us, as we take time off to travel and enjoy the warmer weather. "But it is important to understand what this time of year means for our medicines and medical devices, and take the precautions necessary to use products safely and protect ourselves." Watch out for dodgy hay fever treatments Millions of Britons suffer from hay fever symptoms in the summer. The MHRA advises consulting a healthcare professional to find the best treatment for your symptoms. People are also warned to be cautious of medicines advertised as hay fever treatments but not approved for use in the UK, such as Kenalog. This is a prescription-only steroid injection licensed as a medicine for other conditions, but not for the treatment of hay fever.

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Labetalol 200mg tablets (Tillomed Laboratories Ltd) directed to pharmacies and wholesalers. Manufacturer, Tillomed Laboratories is recalling one batch of Labetalol 200mg tablets due to an error on the foil blister packaging. The incorrect aluminium foil blister packaging states Labetalol 100mg tablets, however it should be labelled as Labetalol 200mg Tablets. This error has occurred at the primary packing operation. Tillomed Laboratories Limited has confirmed the actual tablet contained in the blister is Labetalol 200mg Tablets, which is the strength stated on the outer carton. This error is limited to the packaging of the batch with 100mg aluminium foil blister and does not impact the lot (batch) number or expiry as printed on the outer carton and aluminium foil blister. Healthcare professionals has been advised to stop supplying the batches immediately. Quarantine all remaining stock and return it to supplier using supplier's approved process.

The MHRA's Criminal Enforcement Unit (CEU), working with other law enforcement partners, has seized more than two million "illegally traded medicines" this year, with a total value of £5 million. The products confiscated in the UK were prescription-only medicines including anti-depressants, pain medication and human growth hormones. The MHRA launched an initiative, Operation Pangea, 15 years ago to combat "illegal internet trade in medical" products. Andy Morling, the Deputy Director of Criminal Enforcement of MHRA, spoke about Operation Pangea's 15-year anniversary. "Fifteen years ago, the MHRA started Operation Pangea, combining our knowledge and resources with those of international partners to disrupt and bring to justice the criminal gangs responsible for selling medicines illegally and causing harm around the world.

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) has appointed Anthony Harnden, a professor of primary care at the University of Oxford, as its new Chair. Professor Harnden brings decades of experience to the role. He has served the NHS for 40 years, including 33 years as a general practitioner in Wheatley, Oxfordshire. Until the end of December 2024, he will also continue as a registrant council member of the General Medical Council and chair of the Remuneration Committee. He previously served as deputy chair of the Joint Committee on Vaccination and Immunisation (JCVI), where he played a key role in ensuring public trust and patient safety during the distribution of the COVID-19 vaccine. Professor Harnden succeeds Stephen Lightfoot, who served as MHRA chair from September 2020 until stepping down in 2023. On his appointment, Professor Harnden said: "It is a great honour and privilege to be appointed by ministers to be the next MHRA chair. I am looking forward to making a contribution to the future successes of the organisation.

A couple in Maidenhead, Berkshire has been handed suspended sentence for illegal possession and supply of £1.6m of unlicensed medicines. Following investigations initiated by the MHRA, Karina Filimonova and Andrejs Stolarovs were caught with the unlicensed medicines which included prescription-only medications. Southwark Crown Court sentenced each "to eight months imprisonment suspended for 18 months and 150 hours unpaid work" for possessing and intending to supply medicinal products contrary to the Human Medicines Regulations 2012. "This was a sophisticated operation illegally bringing unlicensed medicines into the UK from Singapore and India, and then distributing them across the country and abroad," said Andy Morling, MHRA Deputy Director of Criminal Enforcement. "Criminals trading in medicines illegally like this are not only breaking the law, but they also have no regard for your safety. These are powerful medicines that can lead to serious adverse health consequences if taken without appropriate medical supervision." In 2020, the Royal Mail Group (RMG) informed the MHRA about parcels containing unlicensed medicines discovered during their investigation into suspicious parcel activity. Following this, the MHRA's Criminal Enforcement Unit, in cooperation with local police, launched an investigation and apprehended the couple at their residence in Kidwells Close, Maidenhead.

The Medicines and Healthcare products Regulatory (MHRA) and Genomics England to launch a brand-new genetic research resource, known as a 'biobank' on Thursday (June 01) to tackle the issue of Adverse Drug Reactions (ADRs). Biobank will help to better understand how a patient's genetic makeup can impact the safety of their medicines. "The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA's Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices," said MHRA. The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. The sequencing of participants' genetic material will begin in Spring 2024, with initial research findings from the pilot due to be published in 2025. Genomics England will be supporting the MHRA with sequencing and storage of genetic material through use of their well-established and secure infrastructure.

The Criminal Enforcement Unit (CEU) of the Medicines and Healthcare products Regulatory Agency (MHRA) seized a large quantity of suspected illegally traded medicines, including powerful prescription-only medicines, during raids conducted at two residential and two business premises across North Manchester. Officers from the MHRA and Greater Manchester Police carried out searches across two residential addresses in Oldham and Cheetham in the early hours of Wednesday (29 November), and arrested a man in his 20s on "suspicion of conspiracy to supply controlled drugs, breaches of the Human Medicines Regulations 2012 and money laundering." They also seized thousands of illegal medicines from two business addresses in Bury and Miles Platting, including powerful opioid painkillers and antidepressants, as well as unlicensed versions of erectile dysfunction drugs.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for Sildenafil 100mg Film-coated Tablets (Strandhaven Limited T/A Somex Pharma). Manufacturer of drug, Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch state 8 tablets instead of 4 tablets. This is an error due to cartons being mixed at the printers. All cartons with batch number ET22028 contain one blister strip of 4 tablets regardless of whether it states 8 tablets or 4 tablets on the pack. Only the batch number ET22028 is affected. Due to the low number of complaints received, only the packs labelled as containing 8 tablets are being recalled at this time. The batch is comprised of 60340 packs, to date 195 packs have been found to be mislabelled.