Medicines and Healthcare products Regulatory Agency

📄 Complete our survey to help us improve our MHRA advice service 💡 We are reviewing how we provide scientific, technical and regulatory advice and guidance to developers of healthcare products, including industry, NHS partners, academia and other professional stakeholders. We are keen to better understand what you think works well with how we provide advice and guidance and ways we could improve this in the future. This includes services offered via: • Formal Scientific Advice Meetings (SAM) for medicines or to support an application for a clinical investigation with associated fees • Guidance or training which might be delivered virtually, for example via webinars, or in person via workshops or meetings • Handling enquiries which provide written or verbal advice on a more ad hoc basis, usually in response to a request from a company/developer. This includes meetings scheduled on request to provide technical advice (non-fee earning) for software medical devices or via AI and digital regulations service (AIDRS) or the Innovation Office. •Guidance, in the form of written guidance available via the website and the British Pharmacopoeia. Understanding the perspective of stakeholders like you is essential, even if you have not directly used this service. The independent research agency, Woodnewton, have designed a short online survey, which should take 10 minutes to complete. All answers will be held in strict confidence and Woodnewton will not present any data to us that allows individual responses to be identified. If you have already completed the survey – thank you! If not, please click here to go to the survey: https://bit.ly/3ZHzdO1 ❗The survey closes 17 December 2024

🛎️The Commission on Human Medicines (CHM) is looking to appoint an expert in Neurology and Dementia to the Neurology, Pain and Psychiatry Expert Advisory Group (NPP EAG) 🛎️ To find out more about this role and to apply, visit 🔗 https://bit.ly/3KgTpxb

📋 🔬 Join us at the MHRA Good Clinical Practice (GCP) and Laboratories Symposium 2025 📅 The symposium will take place on 11-12 February 2025 and be accessed in person in London, and virtually through our newly formatted hybrid symposium. The symposium will provide an opportunity to gain insights from MHRA inspectors, understand the latest regulatory changes, gain valuable knowledge on Good Clinical Practice and Good Laboratory Practice requirements, and prepare your organisation for future inspections. For a full list of topics, please view our programme at the link below. Day two will focus on topics in Labs: • Insights from MHRA Laboratory inspectors on conducting GLP studies • Compliance issues • Inspection findings • Developing compliance approaches To learn more about the symposium and to book your place, visit ➡️ https://bit.ly/40XIanD

📣 Update on our pilot scheme, AI Airlock We have selected 5️⃣ technologies for the AI Airlock, a pilot scheme to better understand how we can regulate artificial intelligence (AI) powered medical devices in a way that that enables getting these types of products to the NHS and patients who need them as quickly and safely as possible. 💡 These novel medical devices have the potential to significantly improve the diagnosis and care of patients. Those selected for the pilot include medical devices for cancer and chronic respiratory disease patients as well as those requiring radiology diagnostic services. Before any medical product can reach patients, there must be evidence to show that it is safe and that it works when used for its intended purpose outside of a study setting. New AI technology makes it challenging to generate this evidence for a number of reasons, including the fact that the medical device changes as it learns. 🔁 In case you need a refresher: AI Airlock is a regulatory “sandbox”, a type of study where manufacturers can explore how best to collect evidence that could later be used to support the approval of their product. This is done under MHRA supervision in a virtual or simulated setting. Doing so will help the manufacturer and the MHRA better understand the challenges of regulating AI in medical devices, leading to a more bespoke and enabling regulatory framework, a clearer route to market for industry and, most importantly, paving the way for quicker NHS and patient access to potentially transformative AI technologies. Our MedTech Regulatory Reform Lead and Chief Officer at the MHRA, Laura Squire OBE, said: “New AI medical devices have the potential to increase the accuracy of healthcare decisions, save time and improve efficiency, leading to better outcomes for the NHS and patients across all healthcare settings. “But we need to be confident that AI-powered medical devices introduced into the NHS are safe, and stay safe and perform as intended through their lifetime of use. “By examining the technologies announced today in a safe setting, in partnership with technology specialists, developers and the NHS, we can test and improve the rules for AI-powered medical devices, helping get products like these to the hospitals and patients who need them sooner.” To read the full announcement, visit ➡️ https://bit.ly/3CTrcfW

📋 🔬 Join us at the MHRA Good Clinical Practice (GCP) and Laboratories Symposium 2025 📅 The symposium will take place on 11-12 February 2025 and be accessed in person in London, and virtually through our newly formatted hybrid symposium. The symposium will provide an opportunity to gain insights from MHRA inspectors, understand the latest regulatory changes, gain valuable knowledge on Good Clinical Practice and Good Laboratory Practice requirements, and prepare your organisation for future inspections. For a full list of topics, please view our programme at the link below. Day one will focus on topics in GCP: • Latest changes to UK Clinical Trials regulations • ICH E6 (R3) GCP implementation • GCP Principles in UK Clinical Trials • Future of GCP inspections To learn more about the symposium and to book your place, visit ➡️ https://bit.ly/40XIanD

📢 Our Clinical Practice Research Datalink (CPRD) team is looking for a Clinical Study Manager in the Safety and Surveillance group 📢 To learn more about the role and to apply, visit ➡️ https://bit.ly/49ai56F

📢 Not long until the British Pharmacopoeia 2025 edition becomes legally effective on 1 January 2025. Order your copy in preparation for any changes. Your comprehensive collection of official standards for UK pharmaceutical substances and medicinal products. Learn more about BP 2025 and order your copy here ➡️ https://bit.ly/4fs7J4C

📣 The deadline for the pharmaceutical industry to get ready for the implementation of the Windsor Framework for medicines is rapidly approaching. We have developed a series of short videos 🖥️ https://bit.ly/3Z4TBHl, summarising key points about the new arrangements for medicines and explaining why it’s so important to take action now to ensure you are ready for its implementation on 1 January 2025. These six very short videos featuring Julian Beach, MHRA’s Executive Director of Quality and Access, are now available in our Windsor Framework Hub 🔗 https://bit.ly/3Zs2CfE Key things that industry needs to know about include information about categorisation of medicines, disapplying the EU Falsified Medicines Directive, and much more. One of the videos explains that Medicines for the UK market will need to display a ‘UK Only’ label ➡️ https://bit.ly/3V9m9OV. Artwork for this must be submitted now to ensure you meet the 31 December 2024 deadline. There are now two ways to submit labelling artwork, watch our short video for more information ➡️ https://bit.ly/3V9m9OV.

📣 The deadline for the pharmaceutical industry to get ready for the implementation of the Windsor Framework for medicines is rapidly approaching. We have developed a series of short videos 🖥️ https://bit.ly/3Z4TBHl, summarising key points about the new arrangements for medicines and explaining why it’s so important to take action now to ensure you are ready for its implementation on 1 January 2025. These six very short videos featuring Julian Beach, MHRA’s Executive Director of Quality and Access, are now available in our Windsor Framework Hub 🔗 https://bit.ly/3Zs2CfE Key things that industry needs to know about include information about categorisation of medicines, disapplying the EU Falsified Medicines Directive, and much more. One of the videos explains that Medicines for the UK market will need to display a ‘UK Only’ label ➡️ https://bit.ly/3V9m9OV. Artwork for this must be submitted now to ensure you meet the 31 December 2024 deadline. There are now two ways to submit labelling artwork, watch our short video for more information ➡️ https://bit.ly/3V9m9OV.

🌍 This week, 18 - 24 November, is World Antimicrobial Resistance Awareness Week To prevent and combat antimicrobial resistance, we are collaborating with the International Coalition of Medicines Regulatory Authorities (ICMRA) and regulators around the world, to facilitate the review of new products and clinical trials to support their development, maintaining appropriate standards for quality, efficacy and safety. Visit 🔗 https://bit.ly/4frdDCS to learn more about our work to conquer this public health threat.