Company Updates

Short Guide on Clinical QMS

A Quality Management System (QMS) is a structured framework implemented to manage and maintain an organisation’s quality objectives and expectations. It is pivotal in ensuring participant safety, data integrity, and compliance with regulatory standards. Our Senior Associate, Rita Silvestre has created a short guide introducing the fundamentals of QMS, focusing on its application in clinical settings. 

Regulatory Updates

EPA, FDA, and USDA issue joint regulatory framework for Biotechnology

On 8^th May, the FDA, US Environmental Protection Agency (EPA), and US Department of Agriculture (USDA) announced the development of a joint plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The plan incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations.

MHRA launches AI Airlock to address challenges for regulating medical devices that use AI

On 9^th May, the Medicines and Healthcare products Regulatory Agency (MHRA) launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD). This will help the agency identify and address the challenges for regulating standalone AIaMDs, initially seeking out and supporting 4-6 virtual or real-world projects through simulation. Using real-world products, the AI Airlock will bring together expertise from within the MHRA and key partners including the UK Approved Bodies, the NHS, and other regulators. The outputs will inform subsequent AI Airlock phases in the short term, and future MHRA guidance and policy in the longer term, while exploring any limitations of existing approaches to demonstrating regulatory compliance.

MHRA guidance updates

• Send and receive information on adverse drug reactions (ADRs). On 9^th May, the MHRA updated the dates of the new adverse incident database deployment in its information on how marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine. 
• Good manufacturing practice (GMP) and good distribution practice (GDP). On 13^th May, information was changed in the ‘GxP inspections from 1 January 2021’ section, referring to GMP inspection outcomes from EEA regulatory authorities continuing to be recognised under a new mutual recognition agreement, rather than until 1 January 2023 as previously mentioned. 
• Apply for a licence to market a medicine in the UK. On 14^th May, a new webinar video on the established medicines licensing process was added to the MHRA overview of the process including submitting or fast-tracking an application, naming your medicine, and paying fees. 

FDA guidance updates

• Remanufacturing of Medical Devices. On 9^th May, the US Food and Drug Administration (FDA) added final guidance intended to help clarify whether activities performed on devices are likely “remanufacturing.”  It also clarifies existing regulatory requirements for remanufacturers and includes recommendations for information that should be included in labelling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. 

Industry Updates

FDA gives green light to first torsemide animal drug for dogs

On 10^th May, the FDA conditionally approved UpCard-CA1 (torsemide oral solution) for use with concurrent therapy with pimobendan, spironolactone, and an angiotensin-converting enzyme (ACE) inhibitor for the management of pulmonary oedema in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD).

BBSRC invests £48m to advance lifelong health research at Babraham Institute

On 10^th May, the Biotechnology and Biological Sciences Research Council (BBSRC) announced the investment of £48m into the Babraham Institute, following a five-year review, to support core research on the key mechanisms that maintain the health of cells, tissues, and organs across the whole life course.

MIT’s new MRI brain light-detecting technique could support future brain cell studies

On 10^th May, the Massachusetts Institute of Technology (MIT) announced its engineers have developed a new technique using magnetic resonance imaging (MRI) to detect light deep in the brain, which could benefit future studies of the development and communication of brain cells. This new technique could enable researchers to explore the inner workings of the brain in more detail than has previously been possible.

Analysis uncovers new insights into the global increase in lethal Strep A infections

On 10^th May, the Imperial College London (ICL), in partnership with the UK Health Security Agency (UKHSA), announced new analysis has confirmed that a variant called M1UK played a significant role in the global increase of group A Streptococcus (Strep A) infection. The research was supported by the National Institute for Health and Care Research (NICE), the UKRI Medical Research Council and the NIHR Imperial Biomedical Research Centre.

Warning issued over Cue Health’s COVID-19 tests due to risk of false results

On 13^th May, the FDA issued a warning to home test users, caregivers, and health care providers not to use Cue Health’s COVID-19 tests for home and over-the-counter (OTC) use and its COVID-19 tests intended for patient care settings due to increased risk of false results.

FDA launches improved Regulatory Science Tools Catalog

On 14^th May, the FDA’s Office of Science and Engineering Laboratories launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability as well as allow for long-term growth in published tools. The RST Catalog is now organised by research program and device type, cross-referenced by both program and RST category, and an online portal for many OSEL-developed applications including the Device and Material Safety Evaluation Library. It will continue to provide peer-reviewed resources for medical device companies and innovators.

Consultation conference: EU guidance on public procurement of medicines

On 15^th May, the European Commission published information on the upcoming consultation conference on EU guidance on public procurement of medicines, taking place on the 23^rd of May 2024. This includes the agenda and how to register.

UK government pledges £85 million to tackle antibiotic emergency

On 16^th May, the UK government announced a package of up to £85 million to support the international community in tackling the growing threat of antimicrobial resistance (AMR), a global issue that makes infections difficult or impossible to treat. This will build on ongoing international and domestic work to prevent the spread of antimicrobial resistance and includes the recently announced National Action Plan and a partnership with countries across Asia and Africa to tackle AMR and reduce the threat posed to the UK, through the Fleming Fund backed by £210 million.

GSK to become a founding partner of Fleming Initiative to fight AMR

On 16^th May, GSK announced it will become the first founding partner of the Fleming Initiative, led by Imperial College Healthcare NHS Trust and Imperial College London to tackle AMR around the world. The company has made a £45m pledge to support the initiative – a new global network of scientific, technology, clinical, policy and public engagement expertise to develop new AMR interventions

Issue Number: WN00162

Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Just send an email to info@towermains.com with the subject “Weekly Newsletter Please.”