Medicines and Healthcare products Regulatory Agency

📢 Our Clinical Practice Research Datalink (CPRD) team is looking for a Data Scientist in the Safety and Surveillance group 📢 To learn more about the role and to apply, visit ➡️ https://bit.ly/3YYfklR

📋 📢 Help shape the future of the British Pharmacopoeia (BP) by having your say We value the views of our BP users, stakeholders and partners in shaping our activities. We would like to know more about how you use the BP and would welcome your feedback via our user survey, which is being carried out by our independent research partner, OKO. At the end of the survey, you will have the chance to enter a prize draw to win £100 (or your local equivalent). Take part here ➡️ https://bit.ly/3z0Bs4m All feedback will be completely anonymous and treated in the strictest confidence.

📣 We have approved a product licence for Lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease Lecanemab is the first treatment for Alzheimer’s disease licensed for use in Great Britain that targets the underlying pathology and shows some evidence of efficacy in slowing the decline including in quality of life and independence for those suffering from the disease. 💡 Lecanemab is approved to treat adults in the early stages of Alzheimer’s disease who have one or no copies of the apolipoprotein E4 gene (APOE4). Julian Beach, our Interim Executive Director, said: “Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us. “We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met. “As with all medical products, we will keep its safety under close review, and with a controlled access programme and safety studies we will ensure that the benefit risk of Lecanemab in clinical use is closely followed up.” To learn more, visit ➡️ https://bit.ly/46Z862T

📣 Award-winning collaboration ensures the voice of patients plays a prominent role in the way cancer therapies are assessed. The Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials (known as SISAQOL-IMI) consortium have received the prestigious SPAIG (the Statistical Partnerships Among Academe, Industry, and Government) Award for 2024 from the American Statistical Association for their work to improve standards in the design and analysis of cancer trials with patient reported outcomes. The international multidisciplinary consortium, which includes experts from the MHRA, is developing a consensus-based set of best practice recommendations for the design, analysis, presentation, and interpretation of patient reported outcome (PRO) data. The award honours years of intensive work and successful cooperation between the stakeholder groups which include patient representatives. This work will help to better communicate patient reported outcome results between clinicians and patients for the purposes of shared decision making. The recommendations are also likely to be applicable to other therapeutic areas beyond oncology. To learn more about SISAQOL-IMI, visit ➡️ https://bit.ly/4fI0TYZ

🔔 The British Pharmacopoeia 2025 edition is now available to order and will become legally effective from 1st January 2025 📌 Get the latest required standards early, to prepare for being compliant by 1st January. To order your copy of the British Pharmacopoeia 2025 and to learn more, visit ➡️ https://bit.ly/3SrqxHp

📢 We have approved a new targeted cancer treatment, given in combination with a standard chemotherapy, for adults with stomach (gastric) or gastro-oesophageal junction cancer. Zolbetuximab (Vyloy) is a monoclonal antibody that can recognise and attach itself to certain cancer cells to destroy them. Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access said: “This new targeted medicine can extend survival for adults with this type of cancer. “MHRA is assured that the appropriate regulatory standards of quality, efficacy and safety for the approval of this new medicine have been met.” Read more here ➡️ https://bit.ly/3SKp0MU

📣 Round up of the #TopTipsforSummer Series 😎 Over the last couple of weeks, we have shared our #TopTipsforSummer series, which featured five top summer tips for people taking medicines or using medical devices. In case you missed it, here is a round up of our advice: 1. Some medicines can lead to reactions with sunlight - some medicines you are taking can cause a reaction to the sun. Make sure to protect your skin from the sun and UV rays. ☀️ 2. Only take weight loss medicines prescribed for you - Wanting to lose weight is a common goal for a lot of people to improve your health. If that’s something you want to do, beware of criminals luring you into a quick fix by offering fake, potentially harmful products online, such as dodgy diet pills or fake weight loss pens. 🍉 3. Beware of dodgy hayfever treatments - Be alert to medicines being advertised as hay fever drugs when they are not approved for UK use. 🌳 💉 4. Travelling through airport security with an implanted medical device - If you are travelling through airports and you have an implanted electronic medical device – including pacemakers, implanted cardioverter defibrillators (ICDs), neurostimulators, hearing implants, infusion pumps and glucose monitoring devices – please carry your device registration card (also known as implant ID card) to show to airport staff before passing through security. ✈️ ⚕️ 5. Be aware of the suitability of medicines for tropical diseases - Travelling abroad could mean being exposed to potentially dangerous diseases. Two examples are yellow fever and malaria – both found in tropical countries and spread by mosquitoes. In both cases, medicines are available to reduce the risk of infection. However, it is always important to consider their suitability for each individual. 🌴 Our Chief Safety Officer, Dr Alison Cave, 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. “From medicines that may lead to reactions with sunlight to safe and effective hay fever treatments, these tips will stand you in good stead during both the summer and any time of the year. And remember, for all medicines it’s important to read the leaflet and speak to a healthcare professional if you have any questions.” To read the full advice for our tips, visit ➡️ https://bit.ly/3YjoARn

📣 We have collaborated with Genomics England to deliver the Yellow Card Biobank study to research severe adverse reactions experienced by some patients to two medications - allopurinol or direct oral anticoagulants. 💡 We want to hear from you if you, or a patient in your care, has had a severe skin reaction when taking allopurinol or excessive bleeding from taking direct oral anticoagulants. By taking part in this study, you’ll be helping researchers to identify groups of people who share genetic traits and experienced similar side effects. Healthcare professionals will use the results of this research to help ensure patients are prescribed the safest medication for them based on their genetic makeup. 🚩 If you or any of your patients have had a severe reaction to these two medications, please submit a Yellow Card report providing as much information as possible about the side effects. We may contact you for more details about yourself or ask you to contact your patient, on our behalf, to see if they are willing to participate in the Yellow Card Biobank study. Find out how to get involved at ➡️ https://bit.ly/3QQE3UX

🍉The fifth and final tip in our #TopTipsforSummer series is Tip #5: Only take weight loss medicines prescribed for you Hear advice from Andy Morling, our Deputy Director of Criminal Enforcement. 🌐 Visit the #FakeMeds website for tools and resources to help you purchase medicines or medical devices safely online, ➡️ https://bit.ly/3YAFNWy To read the full advice, visit 🔗 https://bit.ly/3YjoARn

🍉Today marks the release of the last tip in our #TopTipforSummer series, with Tip #5: Only take weight loss medicines prescribed for you 💪 Wanting to lose weight is a common goal for a lot of people to improve your health. If that’s something you want to do, beware of criminals luring you into a quick fix by offering fake, potentially harmful products online, such as dodgy diet pills or fake weight loss pens. Last year, we warned of the dangers of buying pre-filled pens claiming to contain Ozempic (semaglutide) and Saxenda (liraglutide). People should only use medicines like these where they’ve been prescribed by a qualified healthcare professional. ⚠️ Since January 2023, the MHRA and its law enforcement partners have seized 869 potentially fake Ozempic pens. All were intercepted before they reached the public. Be careful when obtaining medicines online. Fake medicines and medical devices bought online pose significant dangers to your health. If you have a concern about your weight and health, you should visit your GP or pharmacist, get a correct diagnosis and - if medicines are prescribed - obtain them from a legitimate source. All pharmacies in Great Britain, including those online, must be registered with the General Pharmaceutical Council (GPhC) and meet their standards for registered pharmacies. You can find a list of these on the GPhC website ➡️ https://bit.ly/2TG8RtT 🌐 Visit the #FakeMeds website for tools and resources to help you purchase medicines or medical devices safely online, ➡️ https://bit.ly/3YAFNWy To read the full advice, visit 🔗 https://bit.ly/3YjoARn