Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Company Updates
We are thrilled to be attending the BioCap 2024 Conference on Thursday 26th September, hosted by Bionow.
Are you also attending? Our Head of QA, Shona Ross, and Head of Operations, Lianne Roeling, will be there to say hello!
Regulatory Updates
MHRA clarifies terminology in statutory fee consultation
On 10th September, the Medicines and Healthcare products Regulatory Agency (MHRA) clarified some terms in the consultation document relating to Priority 2: The MHRA proposes to amend its existing Medical Device Registration fee to include the costs for medical device post-market work. In this section, the agency has replaced the term ‘category’ with ‘code’ and the term ‘supplier’ with ‘manufacturer’. The consultation closes at 11:59pm on 24th October 2024.
Further MHRA updates
- Assistive technology: definitions, examples and safe use. On 6th September, the MHRA published guidance on the definition of assistive technology and the difference between medical devices and aids in daily living. Click to view source
- Early Access to Medicines Scheme: Overview. On 10th September, new guidance was published to give an overview of the Early Access to Medicines Scheme (EAMS), a scheme that aims to give patients with life-threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeutics. Click to view source
- Wholesalers & manufacturers guidance following agreement of the Windsor Framework. On 12th September, guidance was published to support manufacturers and wholesale dealers authorised by the MHRA and the associated Qualified Persons (QPs), Responsible Persons (RPs) and Responsible Persons for Import (RPis), in order to implement the arrangements of the Windsor Framework for human medicines. Click to view source
EMA and HMA release new guidelines for the use of large language models in medicines regulation
On 5th September, the European Medicines Agency (EMA) announced that, alongside the Heads of Medicines Agencies (HMA), it has issued guidelines for using large language models (LLMs) in medicines regulation. These principles focus on the safe, responsible, and effective use of LLMs to support regulatory tasks, such as automating data mining and improving administrative processes. The guidelines address challenges like data security and accuracy while promoting continuous learning and governance and are part of the EMA’s Artificial Intelligence (AI) work plan through 2028 which aims to maximise the benefits while managing risks associated with AI.
FDA updates
- Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle. On 6th September, the US Food and Drug Administration (FDA) published draft guidance to communicate when and what methods could be used to collect and submit patient preference information (PPI) across the total product life cycle. Click to view source
- Withdrawn Guidances. On 6th September, the FDA updated the list of withdrawn guidances to include Emergency Use Authorization for Vaccines to Prevent COVID-19 – Final. Click to view source
- Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders. On 10th September, final guidance was published to describe the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility’s accreditation, and/or a suspension or revocation of a certificate, and/or a patient and referring provider notification (PPN) order. Click to view source
Industry Updates
Aptar Digital Health announces new asthma clinical study with Guy’s and St Thomas’ NHS Foundation Trust
On 5th September, Aptar Digital Health announced a collaboration with Guy’s and St Thomas’ NHS Foundation Trust to evaluate the impact of Aptar Digital Health’s Respiratory Disease Management Platform, ADH Respiratory DMP, on asthma patients. The clinical study, which began in July 2024 and will run for six months, will recruit 118 adults with moderate to severe asthma, with the primary aim of assessing the improvement of asthma symptom control.
APL and CurifyLabs collaborate to support critically ill patients with 3D printing technology
On 5th September, APL, one of the largest manufacturers of extemporaneous medicines and a leading contract development and manufacturing organisation (CDMO) in Sweden, announced a partnership with CurifyLabs, a Finnish health tech company creating personalised medicine manufacturing solutions, to enhance the administration of medicines to children and critically ill patients using innovative 3D printing technology.
EMA’s PRAC recommends new safety measures to mitigate serious risks of painkiller metamizole
On 6th September, the EMA announced its safety committee (PRAC) has recommended measures to minimise the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. The recommendations include implementing stricter safety warnings and monitoring requirements to minimise risks and ensure patient safety.
PolTREG’s T-cell therapy shows long-term remission in type 1 diabetes
On 9th September, PolTREG S.A., a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, announced data showing that treatment with its Treg cell therapy, PTG-007, resulted in clinical remission for up to 12 years in patients with type-1 diabetes (T1D). The clinical study monitored 54 patients who had taken part in Phase I and Phase II trials with PTG-007 to treat early-onset T1D, over a period between 7 and 12 years.
FDA investigates tampon safety after study detects metals
On 10th September, the FDA announced it has commissioned an independent literature review and initiated an internal study to evaluate metals in tampons. The literature review aims to better understand existing data on chemicals in tampons and their potential health effects. The study will measure the amount of metals released from tampons under conditions similar to normal use. These efforts will enable the agency to complete a risk assessment of metals contained in tampons, based on a worst-case scenario of metal exposure.
FDA warns company for illegally selling unapproved products with unproven health claims
On 10th September, the FDA issued a warning letter to a company for illegally selling cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN) products for people and pets, making unproven claims that these products can treat various conditions including Alzheimer’s disease, substance use disorder, autism, high blood pressure and skin ailments.
FDA issues warning letters to two companies over data quality and integrity concerns
On 11th September, the FDA issued warning letters to two non-clinical testing laboratories for laboratory oversight failures and animal care violations that raise concerns about the quality and integrity of data generated by the labs. The companies provide third-party testing and validation data services to device manufacturers for use in their premarket device submissions to the FDA.
Issue Number: WN00179
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