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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."

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 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 (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 Medicines and Healthcare products Regulatory Agency (MHRA) is doubling down on its efforts to combat online pharmacy frauds, emphasising innovation, eradication of legacy systems, and cybersecurity in its updated technology roadmap. The online sale of medicines and medical devices is a "growing phenomenon offering convenience, anonymity, and lower prices " for the public. However the lack of robust cyber monitoring also "poses significant risks", as many online pharmacies are "unregulated, illegal, or fraudulent." According to the MHRA's recent report highlighting the impact of artificial intelligence on the regulation of medical products, the strategic themes of "fundamental to the successful deployment of AI" are essential for protecting consumers from fraudulent medical products.

Reacting to recommendations from a UK-first independent review, the Department of Health and Social Care (DHSC) has outlined action to tackle potential bias in the design and use of medical devices. Professor Dame Margaret Whitehead, professor of public health at the University of Liverpool, was appointed to lead the review, which focused on three areas - optical devices such as pulse oximeters, AI-enabled devices, and polygenic risk scores (PRS) in genomics. The DHSC commissioned the medical devices review after concerns were raised that pulse oximeters - widely used during the COVID-19 pandemic to monitor blood oxygen levels - were not as accurate for patients with darker skin tones. There were worries that this could cause delays in treatment if dangerously low oxygen levels in such patients were missed. However, no evidence was found from NHS studies indicating that this differing performance had an impact on patient care. Accepting the report's conclusions, the DHSC has committed to several actions, such as ensuring the safe use of pulse oximeter devices across a range of skin tones within the NHS and eliminating racial bias from data sets employed in clinical studies.

Proprietary Association of Great Britain, PAGB - which represents manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements - on Tuesday (12 December) celebrated 40 years of reclassification of medicines. Expanding self-care for common ailments and minor injuries will not only help ease pressure on primary care services, but also provides significant potential savings for the NHS, the consumer healthcare association highlighted during the event. Nurofen (ibuprofen) and Imodium (loperamide) were the first medicines to go through Medicines and Healthcare products Regulatory Agency (MHRA)'s switch process in 1983 to make them available over the counter - OTC. Other reclassified medicines which were once available on prescription only include Voltarol (diclofenac dimethylammonium), Canesten (clotrimazole), Nexium (esomeprazole), Nicorette, Nicotinell and Niquitin (nicotine replacement therapies), Regaine (minoxidil), Viagra Connect (sildenafil), Cialis Together (tadalafil) for erectile dysfunction and Gina (estradiol hemihydrate) for the treatment of postmenopausal symptoms such as vaginal dryness.