Company News
We’re gearing up for two key industry events this autumn!
First, we’ll be exhibiting at BioCap 2025, hosted by Bionow on Thursday, 25th September. It’s a fantastic opportunity to reconnect with familiar faces, meet new contacts, and gain insights from industry leaders on the latest trends and innovations shaping the life sciences.
Next, we’re attending the Diagnostics North East 2025 Conference on Friday, 3rd October at The Catalyst in Newcastle. The theme, “Diagnostics in healthcare, 2035… where will we be, and how do we get there?” promises engaging discussions with innovators, researchers, clinicians, and industry leaders on the future of diagnostics.
Attending? Come say hello!
Our team will be on hand at both events to discuss how we can support your QA needs. For more information, visit www.towermains.com or reach out to us at info@towermains.com.
Regulatory News
ICH Releases Draft Q3E Guideline on Extractables and Leachables
On 1st August, the International Council for Harmonisation (ICH) announced that the Q3E draft “Guideline for Extractables and Leachables” has reached Step 2b and entered the Step 3 public consultation period. The guideline provides a risk-based framework for assessing and controlling leachables from manufacturing components, packaging, or delivery devices, complementing existing impurity guidelines to ensure patient safety and harmonise regulatory expectations.
EU Confirms Continued Use of Titanium Dioxide in Medicines
On 5th August, the European Commission published a Staff Working Document affirming that titanium dioxide (TiO₂) should remain permitted in medicinal products. This decision follows the EMA’s April 2024 analysis, which concluded that replacing TiO₂ in medicines is currently not feasible without compromising quality, safety, or efficacy. The EMA’s findings highlighted challenges such as reduced opacity, limited colour options, and potential impacts on product stability. Given these considerations, the Commission has decided to maintain the use of TiO₂ in medicines while encouraging ongoing research into alternative excipients.
Patients to receive medicines 3–6 months faster under the UK 10‑Year Health Plan
On 6th August, MHRA and National Institute for Health and Care Excellence (NICE) announced a joint initiative under the UK government’s 10‑Year Health Plan to accelerate patient access to new medicines. By enabling parallel review of licensing and NHS guidance, this approach could reduce the time from drug approval to patient availability by 3–6 months. The initiative also provides integrated support for pharmaceutical developers, including early registration via the UK’s horizon‑scanning system, and forms part of a wider effort to streamline regulation and boost the UK life sciences sector.
FDA Launches PreCheck Program to Strengthen Drug Manufacturing
On 7th August, the FDA launched FDA PreCheck, a two-phase program to support domestic pharmaceutical manufacturing and reduce dependence on foreign production. A public meeting will be held on 30th September 2025 to discuss the framework, gather stakeholder input, and address domestic production challenges.
MHRA Achieves WHO-Listed Authority Status, Boosting UK Life Sciences
On 8th August, the MHRA was officially designated a WHO-Listed Authority (WLA) by the World Health Organisation (WHO), joining top regulators like Health Canada and Japan’s MHLW/PMDA. This milestone recognises the UK’s commitment to regulatory excellence, global collaboration, and patient safety, supporting the Life Sciences Sector Plan and 10-Year Health Plan while enabling faster access to innovative medical products worldwide.
MHRA Updates Approach to FDA Warning Letters
On 8th August, the MHRA Inspectorate Blog announced changes to how UK companies should manage US FDA Warning Letters. Companies are now expected to proactively review and assess these letters as part of their quality management processes and notify the MHRA through the Defective Medicines Report Centre (DMRC) or Inspection Action Groups (IAG) if needed. FDA Warning Letters remain advisory and do not automatically indicate enforcement actions
MHRA Warns Parents to Stop Kids’ Magnesium Gummies Containing Undeclared Melatonin
On 18th August, the MHRA advised parents to stop giving Nutrition Ignition Kids Magnesium Glycinate Gummies to children after tests found undeclared prescription-only melatonin in each gummy. The agency has removed the product from online retailers and advises safe disposal. Children experiencing side effects such as headache, dizziness, or abdominal pain should seek medical advice, and any adverse reactions should be reported via the Yellow Card scheme.
FDA Initiates Daily Real-Time Reporting of Adverse Event Data
On 22nd August, the FDA began publishing daily updates of adverse event data from its Adverse Event Reporting System (FAERS). This move aims to enhance transparency and accelerate the identification of safety signals for prescription drugs and therapeutic biologics. The FAERS database compiles reports from healthcare professionals, consumers, and manufacturers, encompassing adverse events, serious medication errors, and product quality complaints.
MHRA Launches Route B Notification Pilot to Streamline Clinical Trial Modifications
On 27th August, the MHRA launched a pilot for the Route B substantial modification process, running from 1st October 2025 to 31st March 2026. The pilot aims to streamline approval of certain clinical trial changes under the new regulations, effective 28th April 2026, offering automatic approval for eligible modifications and 14-day responses to sponsors, enhancing the UK’s risk-proportionate regulatory framework.
EMA and WHO Mark Ten Years of Collaboration to Advance Global Access to Medicines
On 1st September, the European Medicines Agency (EMA) announced the celebration of a decade of formal collaboration with the World Health Organisation (WHO), anchored in a confidentiality arrangement signed in September 2015. This partnership has focused on scientific evaluation, capacity building, and enhancing regulatory efficiency to improve public health worldwide.
EU Launches Stakeholder Consultation on Revised EudraLex Volume 4 – GMP Guidelines: Chapter 1
On 3rd September, the European Commission initiated a public consultation on the revised Chapter 1 of EudraLex Volume 4, covering the Pharmaceutical Quality System under Good Manufacturing Practice (GMP). The update aligns with ICH Q9(R1) on Quality Risk Management, highlighting proactive risk assessment, improved knowledge management, clearer product quality review requirements, and measures to prevent shortages. Comments are invited via the EU Survey tool by 3rd December 2025.
Published Guidance
Medicines and Healthcare products Regulatory Agency (MHRA)
- 1st August: Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance. The MHRA has published advice for manufacturers of DMHTs that qualify as software as a medical device (SaMD) on understanding new post-marketing surveillance rules and examples of how they apply.
- 1st August: Decentralised Manufacturing Master File template. The Decentralised Manufacturing Master File (DMMF) template was added to the MHRA website. This is to be completed for a product-specific DMMF document.
- 18th August: Route B substantial modification pilot. Guidance on a Route B substantial modification was published. A Route B substantial modification refers to a specific category of changes made to a clinical trial approval under the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
- 26th August: Cosmetic Breast Augmentation Risk Awareness Tool. Information was released on the new Cosmetic Breast Augmentation Risk Awareness Tool for patients to use when considering cosmetic breast implant surgery.
US Food & Drug Administration (FDA)
- 19th August: Approaches to Assessment of Overall Survival in Oncology Clinical Trials. The FDA issued draft guidance providing recommendations to sponsors on the assessment of overall survival in randomised oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a pre-specified safety endpoint.
- 19th August: Oncology Therapeutic Radiopharmaceuticals: Dosage Optimisation During Clinical Development. The FDA issued draft guidance to assist sponsors in identifying an optimised dosage(s) (administered activity and schedule) for radiopharmaceutical therapies (RPTs) for oncology indications during clinical development and before submitting a marketing application for a new indication and usage.
European Medicines Agency (EMA)
- 2nd September: Commission staff working document on the use of titanium dioxide in medicinal products. The European Medicines Agency (EMA) published a decision updating the rules for Seconded National Experts (SNEs), which will apply from 1 October 2025. These rules set out how experts from EU member states, EFTA countries, and certain other eligible organisations can be temporarily seconded to work at EMA.
Updated Guidance
MHRA
- 4th August: COVID-19 test validation approved products. An update for ‘Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations’ was added.
- 7th August: MORE Submissions – user reference guide. A step-by-step guide on using the MORE Platform for Submissions of device-related incidents.
- 8th August: MHRA phase I accreditation scheme. The ‘List of accredited phase I units’ was updated.
- 14th August: Cancel a medicine’s marketing authorisation or other licence. The cancellation form attachment was updated.
- 21st August: Clinical trials for medicines: apply for approval in the UK. The link to the feedback questionnaire was removed after the questionnaire was closed.
- 22nd August: Clinical trials for medicines: apply for authorisation in the UK. Updated information on In Vitro Diagnostic (IVD) Devices, including Companion Diagnostic Devices.
- 27th August: Clinical investigations for medical devices. A new flow chart and guidance documentation for the UK and Northern Ireland were added.
- 2nd September: Make a payment to MHRA. Information was updated to clarify that Device Registration and Certificates of Free Sale for medical device fees must be made only through the Device Online Registration system (DORS).
- 2nd September: Medicines: apply for a parallel import licence. The Tell and Do (TaD) cover sheet for PLPI companies has been updated.
FDA
- 18th August: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. The FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness.
- 22nd August: Animal Studies for Dental Bone Grafting Material Devices – Premarket Notification (510(k)) Submissions. This guidance provides the FDA’s recommendations on animal studies to support premarket notification (510(k)) submissions for dental bone grafting material devices.
- 27th August: CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products. This newly published guidance details the regulatory oversight of articles, including substances, for use in or on mosquitoes (“mosquito-related products”).
Industry News
New review Highlights Potential of the Vaginal Microbiome in Women’s Health
On 7th August, the MHRA published a review emphasising the significant, yet underexplored, role of the vaginal microbiome in women’s health. Collaborating with institutions such as King’s College Hospital London, the University of Liverpool, Ewha Women’s University, and Biowave W Seoul, the review suggests that vaginal microbiome diagnostics could transform the detection and management of conditions like infertility, miscarriage, preterm birth, gynaecological cancers, and menopause-related complications. The review advocates for increased research and development in this area to enhance diagnostic accuracy and treatment personalisation for women’s health issues.
MHRA Approves Teplizumab to Delay Progression of Type 1 Diabetes
On 14th August, the MHRA approved teplizumab, marking the UK’s first immunotherapy for type 1 diabetes. This treatment delays the onset of Stage 3 type 1 diabetes by an average of three years in adults and children aged 8 years and older with Stage 2 type 1 diabetes. Administered as a 14-day intravenous infusion, teplizumab was approved through the International Recognition Procedure, allowing the MHRA to consider the expertise of trusted regulatory partners.
Sever Pharma Expands Collaboration with Silo Pharma on Ketamine Implant
On 14th August, Sever Pharma Solutions announced an expanded partnership with Silo Pharma to advance SP-26, a ketamine-loaded subcutaneous implant for chronic pain and fibromyalgia. Sever Pharma will scale up production and refine the controlled-release formulation, supporting potential FDA approval via the 505(b)(2) pathway and offering a non-opioid treatment option for patients.
First Immunotherapy for Adult RRP Approved in US
On 15th August, the FDA granted full approval to Papzimeos, making it the first and only approved treatment for adults with recurrent respiratory papillomatosis (RRP), a rare disease caused by persistent HPV 6 and 11 infections that lead to benign tumours in the respiratory tract. Clinical trial results showed a 51% complete response rate with no dose-limiting toxicities, highlighting its safety and efficacy, and marking a historic milestone for the RRP patient community.
HHS Authorises FDA Emergency Use of Animal Drugs to Combat New World Screwworm
On 19th August, the US Department of Health and Human Services (HHS) allowed the FDA to grant Emergency Use Authorisations (EUAS) for animal drugs to treat or prevent infestations by the New World Screwworm, a parasitic fly threatening livestock, pets, and wildlife. While risk to humans is low, the parasite poses a significant threat to animal health and the U.S. food supply.
Friends of Cancer Research Advances Interpretation of Interim OS Data in Oncology
On 19th August, Friends of Cancer Research partnered with MMS Holdings to improve how interim overall survival (OS) data in oncology trials are interpreted. Using MMS’s KerusCloud® platform, the initiative will develop frameworks and simulations to guide decision-making for accelerated FDA approvals, addressing challenges like limited data maturity, treatment crossover, and delayed effects.
Anne White to Step Down as EVP and President of Lilly Neuroscience after three decades
On 20th August, Eli Lilly and Company announced that Anne White, Executive Vice President and President of Lilly Neuroscience, will retire on 31st December 2025 after a 30-year tenure. White has been instrumental in advancing treatments for neurodegenerative diseases, pain, substance use disorders, and psychiatric conditions. Under her leadership, Lilly launched its first-ever Alzheimer’s treatment and expanded its neuroscience portfolio. She also played a key role in reducing drug development timelines and led the acquisition of Loxo Oncology.
ANGLE CEO Discusses Blood-Based Cancer Testing Collaboration with Myriad Genetics
On 20th August, ANGLE plc released a video interview featuring CEO Andrew Newland, where he elaborated on the company’s collaboration with Myriad Genetics to explore blood-based cancer testing. The partnership aims to assess whether circulating tumour cell (CTC) DNA, captured using ANGLE’s Parsortix system, can be used alongside Myriad’s existing tissue-based diagnostic assays. This approach seeks to offer a less invasive and potentially faster alternative to traditional tissue biopsies, enhancing patient access to genomic information for precision oncology.
Encare’s EIAS Gains Qualification on Mayo Clinic Platform
On 26th August, Encare AB announced that its ERAS® Interactive Audit System (EIAS) has been qualified as a solution on the Mayo Clinic Platform Solutions Studio. This distinction, rarely awarded to European solutions, underscores EIAS’s clinical relevance, operational robustness, and potential for global impact. Developed in collaboration with the ERAS® Society, EIAS enables hospitals to monitor and improve adherence to Enhanced Recovery After Surgery (ERAS) protocols across multiple surgical specialities.
MHRA Approves Zuranolone for Postnatal Depression
On 27th August, the MHRA approved zuranolone for the treatment of moderate to severe postnatal depression (PND) in adults following childbirth. This marks the first oral treatment for PND approved in the UK. Healthcare professionals are encouraged to report any adverse reactions through the Yellow Card scheme.
MHRA Approves First New Antibiotic for UTIs in Nearly 30 Years
On 28th August, the MHRA approved gepotidacin, the UK’s first new oral antibiotic for uncomplicated urinary tract infections (UTIs) in women aged 12 and older. Gepotidacin works by targeting key bacterial enzymes, making it effective against many drug-resistant infections, including E. coli. The recommended course is two tablets twice daily for five days, with common side effects including mild diarrhoea and nausea.
eXmoor Pharma and Anthony Nolan Partner to Streamline Cell Therapy Development
On 2nd September, eXmoor Pharma and Anthony Nolan’s Cell Therapy & Laboratory Services (CT&LS) announced a partnership to provide end-to-end support for autologous and allogeneic cell therapy developers. The collaboration combines eXmoor’s GMP manufacturing with Anthony Nolan’s donor sourcing, screening, and apheresis expertise, aiming to streamline the path from starting material to clinical supply while ensuring compliance and prioritising patient and donor welfare.
Warning issued due to sharp increase in illegal medicines sold in the EU
On 3rd September, the European Medicines Agency (EMA), in cooperation with the Heads of Medicines Agencies (HMA), issued a strong warning about a significant increase in illegal medicines being advertised and sold online throughout the European Union, particularly products purporting to be GLP-1 receptor agonists such as semaglutide, liraglutide, and tirzepatide, commonly used for diabetes and weight loss.
Continuous Learning for QA Professionals: Staying Ahead in a Rapidly Evolving Industry
In highly regulated industries like pharmaceuticals, biotech, and clinical research, staying up to date isn’t optional, it’s essential. Continuous learning helps Quality Assurance (QA) professionals stay up to date with the latest best practices, principles and compliance standards to ensure that products and services meet the highest levels of quality, safety, and regulatory compliance.
Our latest article explores why ongoing development is crucial, how to identify skill gaps, and strategies organisations can use to create a culture of growth and learning. Plus, learn about Tower Mains’ upcoming learning platform – a flexible, on-demand training solution designed to make training more accessible. With bite-sized modules, interactive content, and built-in progress tracking, it empowers QA professionals to learn at their own pace, wherever they are.
Issue Number: WN00201
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